value proposition slide deck - corail pinnacle · 2 overview this slide deck has been developed to...

Value messaging and accompanying evidence

identified from the Direct Anterior Approach

(DAA) and CORAIL®/PINNACLE® systematic

reviews

Version 9.0

15 April 2016

VALUE PROPOSITION SLIDE DECK

DSEM/JRC/0116/0614 April 2016

2

Overview

• This slide deck has been developed to summarise the evidence (identified in 2 previously commissioned systematic

reviews, and a more recently published literature review) that will be used in the developement of an evidence-based

value proposition to support DePuy Synthes Companies commercial strategy:

o Advocating the DAA as the primary surgical option for THA

o Consideration of CORAIL/PINNACLE as components of choice for THA

o Use of a traction table as an integral component for THA

• The slide deck is divided into 2 sections (DAA and CORAIL/PINNACLE) with separate appendices for each section

provided at the end of the slide deck. Results that favour DAA or CORAIL/PINNACLE or are neutral are presented

under value messages. Results that contradict the value messages identified are also presented after each value

message (where relevant). Details of systematic review methodology are presented in appendices

o Where feasible, we have identified evidence specific to the use of a traction table

• The purpose of this deck is to summarise the value messaging developed, and the evidence that supports it

3

Colour coding

• Each section of the evidence review begins with a table summarising the evidence identified by outcome. In this

table, the strength of evidence for each outcome is evaluated and colour coded: green indicates strong/reasonably

strong evidence, orange indicates moderate strength of evidence, and red indicates weak evidence

• In the DAA section, comparative evidence for each outcome is colour coded according to whether the evidence is in

favour of DAA, neutral, or not favourable for DAA:

o Green outlines indicate evidence that is in favour of DAA

o Orange outlines indicate evidence that is neutral for DAA

o Red outlines indicate evidence that is not favourable for DAA (appendices only)

o Non-comparative evidence is outlined in dark blue

• In the DAA section, studies reporting the operating table(s) used are indicated in bold text

• In the CORAIL/PINNACLE section, all evidence presented is non-comparative. In the absence of comparative data,

evidence have been marked as favourable (outlined in green) or not favourable (outlined in red) based on

benchmarks as described in the notes section of this slide

4

Assumptions

Favourable/non-favourable outcomes in non-comparative studies:

• Theatre time: A good outcome for theatre time was considered to be 60-90 minutes(1)

• Length of stay: A good outcome for length of stay was considered to be 3-5 days(2)

• Revision rate/survivorship: A good outcome for revision rate/survivorship (depending on follow-up time) was ≥95% at 10 years survival

(3)

• Radiographic outcomes: For stem subsidence, no clinically significant ≥3 mm may be acceptable at short follow-up:

Medical (Mick Borroff). For cup migration, no clinically significant ≥1 mm was considered acceptable: Medical (Mick

Borroff)

• Harris Hip Score: (pain, function, deformity, range of motion):<70 poor: -, 70–80 fair: 0, 80–90 good: +, 90–100

excellent : +

• Oxford Hip Score: (pain & function scores; daily activities, e.g. walking & sleeping):<27 poor: -, 27–33 fair: 0, 34–41

good: +, >41 excellent: +

• WOMAC: (pain, stiffness and function): depending on version of scale used, higher is better or lower is better

5

Abbreviations

• C/P CORAIL/PINNACLE

• DAA Direct Anterior Approach

• HHS Harris hip score

• ICU Intensive care unit

• IQR Interquartile range

• LOS Length of stay

• NJR National joint registry

• NS Not significant

• OHS Oxford hip score

• RCT Randomised controlled trial

• SD Standard deviation

• THA Total hip arthroplasty

• VAS Visual analogue scale

• WOMAC Western Ontario and McMaster Universities Arthritis Index

Value theme 1: Inpatient value

• Theatre time

• Length of stay

Comparative studies reporting evidence in

favour of DAA are outlined in green

Comparative studies reporting neutral

evidence for DAA are outlined in orange

Non-comparative studies are outlined in dark

blue

7

Duration of surgery does not increase with DAA compared with other

widely-used THA approaches, and decreases with surgeon experience of

DAA

8

Theatre time is generally similar for DAA and other widely-used THA approaches (1)

Supporting evidence Study details and patient population

Evidence comparing DAA with the anterolateral approach

• In a prospective cohort study, theatre time was similar between patients who underwent THA using the DAA, the

anterolateral approach, or the Hardinge lateral approach(4)

Prospective cohort

study (Romania)

N=180; patients who underwent THA

using either the DAA (n=60), the

anterolateral approach (n=60), or the

Hardinge lateral approach (n=60)

• In a RCT comparing patients who underwent THA using either the DAA or the modified anterolateral approach,

no significant difference in the mean duration of surgery was reported between the study arms(5)

RCT (Japan) N=201 (hips); patients who underwent

THA using either the DAA (n=100

hips) or the modified anterolateral

approach (n=101 hips)

• In a RCT comparing patients who underwent THA using either the DAA or the anterolateral approach, the mean

duration of surgery was similar between groups. The mean (range) duration of surgery was 70 (60-85) minutes in

the DAA group and 70 (60-89) minutes in the anterolateral approach group(6)

RCT (Austria) N=33; patients who underwent primary

THA using either the DAA (n=16) or

the anterolateral approach (n=17)

Evidence comparing DAA with the lateral approach

• The mean±SD operative time was significantly shorter in patients who underwent THA using the DAA

(132.52±24.68 minutes) compared with those who underwent THA using the direct lateral approach

(140.23±27.38 minutes) (p=0.006)(7)

Retrospective

analysis (USA)


using the DAA (n=75) or the direct

lateral approach (n=244)

9


Evidence comparing DAA with the lateral approach ctd.

• In a retrospective review of patients who underwent THA and were prospectively entered into a clinical database,

the mean duration of surgery was similar for THA using the anterior supine intermuscular approach (69 minutes)

and the direct lateral approach (68 minutes) (p=0.7)(8)

Retrospective review

(country not reported)

N=630; patients (main diagnosis of

osteoarthritis) who underwent primary

THA using the anterior supine

intermuscular approach (n=258) or the

direct lateral approach (n=372)

• In a prospective cohort study, theatre time was similar for patients who underwent THA using the DAA, the

anterolateral approach, or the Hardinge lateral approach(4)

Prospective cohort

study (Romania)


using either the DAA (n=60), the

anterolateral approach (n=60), or the

Hardinge lateral approach (n=60)

• In a RCT comparing patients who underwent THA using either the DAA or the direct lateral approach, the

approaches were associated with a similar duration of surgery. The mean (range) duration of surgery was 57 (35-

90) minutes in the DAA group and 55 (36-100) minutes in the direct lateral approach group(9)

RCT (USA) N=79; patients who underwent THA

using either the DAA (n=43) or the


• In a RCT comparing patients who underwent primary THA using a DAA or the direct lateral approach, there was

no significant difference between groups in terms of the mean duration of surgery (p=0.54). The mean (range)

duration of surgery was 56.42 (35-90) minutes in the DAA group and 54.88 (36-100) minutes in the direct lateral

approach group(10)

RCT (USA) N=100; patients with a diagnosis of

arthritis who underwent primary THA

using either single-incision Smith-

Peterson DAA (n=50) or the direct


• In a prospective analysis comparing patients who underwent THA using either the DAA or the lateral

transgluteal approach, there was no significant difference between groups in terms of the mean duration

of surgery (p value reported as not significant). The mean (range) duration of surgery was reported as 78

(65-140) minutes in the DAA group and 85 (70-115) minutes in the lateral transgluteal approach group(11)

Prospective

analysis (Croatia)


using either the DAA with a

standard orthopaedic table with a

leg holder (n=35) or the lateral

transgluteal approach (n=35)


10


Evidence comparing DAA with the posterior approach

• In a prospective analysis of patients who underwent THA using either the Hueter, Moor, or Gibson’s approach,

there was statistically significant variation regarding the duration of surgery between patients in the Hueter

approach group and those in the Moor or Gibson’s approach groups (p=0.0000 for both). There was no

statistically significant variation regarding duration of surgery between patients undergoing THA using the Moor

approach or the Gibson’s approach (p=0.1374)(12)

Prospective analysis

(Bosnia and

Herzegovina)

N=126; patients who underwent

primary THA using the Hueter (most

medial [n=34]), Moor (n=56), or

Gibson’s posterolateral (n=46)

approach

• The mean±SD operative time was significantly shorter in patients who underwent THA using the DAA (78±17.9

minutes) compared with those who underwent THA using the posterior approach (118±19.4 minutes)

(p=0.00)(13)


(USA)

N=57; patients with osteoarthritis who

underwent primary THA using the DAA

(n=29) or the posterior approach

(n=28)

• In a retrospective analysis comparing patients who underwent THA using one of two minimally invasive

approaches, there was no significant difference in the mean duration of surgery between patients who underwent

THA using the DAA (mean±SE: 104.7±2.9 minutes) and those who underwent THA using the mini-posterior

approach (mean±SE: 100.4±3.0 minutes) (p=0.304)(14)

Retrospective

analysis (Japan)

N=182 (195 hips); patients with a

primary diagnosis of secondary

osteoarthritis who underwent THA

using either the DAA (n= 99 hips) or

the mini-posterior approach (n=96

hips)

• In a prospective analysis comparing patients who underwent THA using either the anterior approach or the

posterolateral approach, there was no significant difference between groups in terms of the mean duration of

surgery (p=0.056). The mean duration of surgery was 99.5 minutes in the anterior approach group and 81

minutes in the posterolateral approach group(15)


(The Netherlands)


using either the anterior approach

(n=10) or the posterolateral approach

(n=10)


11


Evidence comparing DAA with the posterior approach ctd.

• In a prospective comparison between patients who underwent THA using either the DAA or the posterior

approach, there was no significant difference between groups in terms of the mean duration of surgery

(p=0.09). The mean±SD duration of surgery was 90±15 minutes in the DAA group and 85±14 minutes in

the posterior approach group(16)

Prospective

comparative study

(USA)

N=120; patients with unilateral

osteoarthritis of the hip who

underwent primary THA using the

DAA (using a standard operating

table and a table-mounted femoral

elevator) (n=60) or the posterior

approach (n=60)

• In a retrospective chart review comparing patients who underwent primary THA using either the DAA or the

posterior approach, there was no significant difference between groups in terms of the mean duration of surgery

(p=0.205). The mean±SE duration of surgery was 109±3.2 minutes in the DAA group and 102±3.8 minutes in

the posterior approach group(17)

Retrospective chart

review (USA)



posterior approach (n=100) with a

CORAIL stem and a PINNACLE cup

• In a retrospective review of patients who underwent THA using either the DAA as part of the surgeon’s learning

curve, the DAA following the initial learning curve, or the posterior approach, there was no significant difference

between the DAA following the initial learning curve and the posterior approach in terms of the duration of

surgery (mean±SD 82.4±16.6 minutes for the DAA and 87.8±20.0 minutes for the posterior approach;

p=0.3433). During the learning curve for the DAA, the mean duration of surgery (mean±SD: 102.7 minutes) was

significantly higher than for THA using the DAA following the initial learning curve and using the posterior

approach (p<0.0001 and p<0.0005, respectively)(18)


(USA)


using either the DAA (n=50 during the

surgeon’s learning curve and n=50

subsequent cases), the posterior

approach (n=50)


12

Contradictory evidence Study details and patient population


• In a retrospective analysis, the DAA was associated with a mean±SD surgery time of 89±19 minutes,

compared with a mean±SD surgery time of 81±15 minutes in patients who underwent THA using the lateral

approach(19)

Retrospective

analysis (Italy)


primary THA (main diagnosis was

coxarthrosis) using either the DAA

(n=221) or lateral approach (n=198)

• In a prospective cohort study, the median duration of surgery was longer for patients undergoing THA using the

minimally invasive anterior approach compared with the lateral trangluteal approach (119 vs 107 minutes;

p<0.001)(20)

Prospective cohort

study (Switzerland)

N=255; patients undergoing elective

primary THA using the minimally

invasive anterior approach with a

standard trauma table (n=113) or the

standard lateral transgluteal approach

(n=142)

• In a prospective analysis, the anterior supine intermuscular approach was associated with a significantly longer

mean theatre time compared with the modified Hardinge approach (73 vs 56 minutes; p<0.01)(21)


(USA)


primary THA using either the anterior

supine intermuscular approach

(n=182) or the modified Hardinge

approach (n=77)

• In a retrospective analysis, patients who underwent THA using the anterior mini-invasive approach had a

significantly longer operative time than patients who underwent THA using the lateral Hardinge approach

(p<0.001)(22)

Retrospective

analysis (country not

reported)


using either the anterior mini-invasive

approach (n=100) or the lateral

Hardinge approach (n=100)

Contradictory evidence: Theatre time is generally similar for DAA and other widely-

used THA approaches (1)

13



• In a RCT comparing THA using the DAA with THA using the posterolateral approach, the operative time was

longer for the DAA group (p<0.05)(23)


(main diagnosis was osteoarthritis)


posterolateral approach (n=45)

• In a RCT comparing THA using the DAA with THA using the posterolateral approach, the mean±SD

surgery time was 84.3±12.4 minutes in the DAA group and 60.5±12.4 in the posterolateral approach

group(24)

RCT (USA) N=87; patients with non-

inflammatory degenerative joint

disease who underwent primary

THA (with a CORAIL stem and a

PINNACLE cup) using the DAA with

a modern fracture table and a C-arm

(n=43) or the posterolateral

approach (n=44)

• In a retrospective comparative study, mean±SD operative time was 103±18 minutes in the DAA learning

curve group, 90±15 minutes in the DAA group, and 84±14 minutes in the posterior approach group(25)

Retrospective

comparative study

(USA)


primary THA using the DAA

(n=286), the posterior approach

with a standard operating table and

table-mounted femoral elevator,

and with fluoroscopy (n=293), or

those forming part of the DAA

learning curve (n=96)

Contradictory evidence: Theatre time is generally similar for DAA and other widely-

used THA approaches (2)

14

Theatre time for DAA is generally 60-90 minutes, with times as low as 52 minutes

reported (1)


Non-comparative evidence for DAA

• In a prospective analysis of 100 primary THAs using the Smith-Peterson DAA with a HANA traction table,

the mean (range) duration of surgery was 53 (34-87) minutes(26)

Prospective review

(USA)

N=100; consecutive patients who

underwent THA using the Smith-

Peterson DAA

• In a retrospective analysis of 906 patients who underwent THA using the anterior supine intermuscular approach,

the mean (range) duration of surgery was 63.6 (10-143) minutes(27)

Retrospective


reported)


primary or revision THA using the

anterior supine intermuscular

approach


the mean (range) duration of surgery was 63.1 (29-143) minutes(28)

Retrospective

analysis (USA)


using the anterior supine

intermuscular approach

• In a prospective analysis of 500 patients who underwent primary THA using the Smith-Peterson DAA with

a traction table (ProFX or HANA), the mean (range) duration of surgery was 70 (45-132) minutes(29)

Prospective

analysis (USA)


primary THA using the Smith-

Peterson DAA with a ProFX or a

HANA traction table

• In a prospective analysis of 100 patients who underwent primary THA using the DAA with a Rotex table

and a modified retractor system, the mean (range) duration of surgery was 80 (55-130) minutes(30)

Prospective

analysis

(Switzerland)


primary THA using the DAA with a

Rotex table and modified retractor

system

• In a retrospective analysis of 100 patients who underwent primary THA using the DAA with a leg-

positioner Rotex table, the mean±SD duration of surgery was 81±14.6 minutes(31)

Retrospective

analysis (country

not reported)

N=100; patients (main diagnosis

was osteoarthritis) who underwent

primary THA using the DAA with a

leg-positioner Rotex table

15


Non-comparative evidence for DAA ctd.

• In a retrospective analysis of 903 patients who underwent THA using the anterior approach, the mean (range)

duration of surgery was 88 (35-330) minutes(32)

Retrospective

analysis (USA)



anterior approach

• In a retrospective analysis of patients who underwent THA using a cemented or cementless stem with a

noncomplex or complex anterior approach, the mean±SD duration of surgery for each of the combinations were:

51±13.2 minutes for the cemented stem/noncomplex anterior approach, 76±27.5 minutes for the cemented

stem/complex anterior approach, 60.4±15 minutes for the cementless stem/noncomplex anterior approach, and

82.9±29.6 minutes for the cementless stem/complex anterior approach(33)

Retrospective

analysis (USA)

N=2,132; patients who underwent THA

using a cemented stem and

noncomplex anterior approach

(n=1,177) or complex anterior

approach (n=104), or a cementless

stem and noncomplex anterior

approach (n=672) or complex anterior

approach (n=179)

• In a retrospective analysis, patients who underwent THA using a conventional DAA had a mean±SD duration of

surgery of 61±15.8 minutes compared with a mean duration of 56±10.7 minutes in patients who underwent

THA using a DAA with computer navigation (p<0.0001)(34)

Retrospective chart

review (USA)


primary THA using either the

conventional DAA (n=150) or a

navigation DAA (n=150)

• In a retrospective analysis of patients who underwent THA using the anterior approach, the mean (range)

duration of surgery was 64 (35-130) minutes(35)

Retrospective

analysis (USA)

N=85; patients who underwent primary

or revision THA using the anterior

approach

• In a retrospective analysis of patients who underwent bilateral THA using the anterior approach with a

Judet or ProFX table, the mean (range) duration of surgery was 1.14 (0.66-2.33) hours(36)

Prospective

analysis (USA)


simultaneous bilateral THA using

the anterior approach with a Judet

or ProFX table


reported (2)

16



• In a retrospective analysis of patients who underwent primary THA using the single-incision anterior

approach with a Judet or ProFX table, the mean (range) duration of surgery was 75 (40-150) minutes(37)

Retrospective

analysis (USA)


primary THA using the single-

incision anterior approach with a

Judet or ProFX table

• The mean duration of surgery was 1.5 hours in patients who underwent primary THA using the anterior

approach(38)

Retrospective

analysis (USA)


primary THA using the anterior

approach with a Judet or ProFX

table

• The mean duration of surgery in patients who underwent THA using the DAA was 58 minutes(39) Prospective analysis

(Iran)



• The mean duration of surgery in patients who underwent THA using the anterior approach was 67.4 minutes(40) Prospective analysis

(USA)



approach

• The mean (range) duration of surgery in patients who underwent THA using the DAA was 79 (45-150) minutes(41) Prospective analysis

(Japan)


THA (main diagnosis was

osteoarthritis) using the DAA

• The mean duration of surgery in patients who underwent THA using the DAA was 87 minutes(42) Retrospective

analysis (USA)


using the DAA

• The mean (range) duration of surgery in patients who underwent THA using the minimally invasive anterior

approach was 52 (45-130) minutes(43)



N=1,000; patients who underwent THA

using the anterior minimally invasive

approach


reported (3)

17

Contradictory evidence: Theatre time for DAA is generally 60-90 minutes, with

times as low as 52 minutes reported Contradictory evidence Study details and patient population

Non-comparative evidence

• In a retrospective analysis of 1,152 patients who underwent primary THA using the single incision anterior

approach, the mean±SD operative time was 95.3±34.9 minutes(44)

Retrospective

observational study

(USA)

N=1,152; patients who underwent

primary THA using the single incision

anterior approach

• In patients with and without paresthesia, mean±SD operative times were 123.8±5.9 minutes and 112.9±2.5

minutes, respectively(45)

Retrospective chart

review (country not

reported)

N=81; hips undergoing anterior supine

THA (patients with or without

paresthesia)

• In a retrospective analysis of patients who underwent THA using the DAA, the mean±SD time of surgery was

114±28.9 minutes(46)

Retrospective

analysis (Sweden)

N=200; consecutive cases of unilateral

THA using the DAA

• In a RCT including patients who underwent THA using the DAA, the mean±SD (range) surgical time was

115±26 (60-180) minutes(47)

RCT (Switzerland) N=120; patients with osteoarthritis who

underwent THA using the DAA with an

extension-distraction table (AMIS

mobile leg positioner) and either no

drain (n=40), a closed suction 3.5 mm

drain connected to a vacuumed (−900 mbar) drainage bottle (n=40), or an

ABTrans autologous retransfusion

system (n=40)

• Mean surgery time was 132.8 minutes in the first 100 THA cases, 109.9 minutes in the second 100 cases,

and106.1 minutes in the third 100 cases(48)


(USA)

N=300; THAs performed using the

DAA (cases were grouped [in 100s]

based on chronological order)

• The mean (range) surgical time in patients who underwent primary THA using the anterior approach with an OSI

Profix table was 164 (81-378) minutes(49)

Retrospective

analysis (USA)

N=231 (247 hips); patients who


anterior approach with an OSI Profix

table

18




curve, the DAA following the initial learning curve, or the posterior approach, there was no significant difference

between the DAA following the initial learning curve and the posterior approach in terms of the duration of

surgery (mean±SD: 82.4±16.6 minutes for the DAA and 87.8±20.0 minutes for the posterior approach;

p=0.3433). During the learning curve for the DAA, the mean duration of surgery (mean±SD: 102.7 minutes) was

significantly higher than for THA using the DAA following the initial learning curve and using the posterior

approach (p<0.0001 and p<0.0005, respectively)(18)


(USA)




subsequent cases), or the posterior

approach (n=50)

Duration of surgery decreases with surgeon experience of DAA

19

Theatre time is generally similar for DAA and other widely-used THA approaches, including the anterolateral, lateral, and posterior approaches

Theatre time for DAA is generally 60-90 minutes with times as low as 52 minutes reported

Duration of surgery decreases with surgeon experience of DAA

Duration of surgery does not increase with DAA compared with other

widely-used THA approaches, and decreases with surgeon experience of

DAA

20

Evidence indicates that length of stay can be reduced with DAA compared

with lateral and posterior approaches, and decreases with surgeon

experience of DAA

21

Length of stay is similar or reduced with DAA compared with lateral and posterior

approaches (1)



• The mean length of hospital stay was significantly lower in patients who underwent primary THA using the DAA

compared with those who underwent THA using the lateral approach, with a mean±SD length of stay of

7±2 days in the DAA group and 10±3.5 days in the lateral approach group (p<0.0005)(19)

Retrospective

analysis (Italy)





• In a retrospective analysis of patients who underwent primary THA using either the anterior approach or the

lateral approach, length of stay was significantly associated with approach (lateral vs anterior approach, odds

ratio 3.38 [95% CI: 2.14-5.33], p<0.0001)(50)

Retrospective

analysis

(The Netherlands)


primary THA in a fast-track setting

using either the anterior approach or

the lateral approach

• The mean length of hospital stay was significantly lower in patients who underwent primary THA using the

modified Smith-Peterson DAA compared with those who underwent THA using the Bauer approach, with a

mean±SD length of stay of 10.2±8.3 days in the DAA group and 13.4±11.7 days in the Bauer approach group

(p=0.0001)(51)

Retrospective

analysis (Germany)


using either the modified Smith-

Peterson DAA (n=100) or the Bauer

approach (n=100)

22



• In a prospective cohort study, the median duration of hospitalisation was significantly shorter in the minimally

invasive surgery group than the standard lateral transgluteal group (11.0 vs 12.0 days; p<0.001)(20)

Prospective cohort

study (Switzerland)





standard lateral transgluteal approach

(n=142)

• In a retrospective analysis, patients who underwent THA using the anterior mini-invasive approach had a

significantly shorter hospital stay than patients who underwent THA using the lateral Hardinge approach

(p<0.001)(52)

Retrospective


reported)


using either the anterior mini-invasive

approach (n=100) or the lateral

Hardinge approach (n=100)

• No significant difference was reported in the mean length of stay of patients who underwent primary THA using

the anterior supine intermuscular approach (1.8 days) compared with those who underwent primary THA using

the direct lateral approach (2 days) (p=0.1)(8)








• In a RCT comparing patients who underwent THA using the DAA or the direct lateral approach, the mean length

of stay was 2.7 days in the DAA group and 2.5 days in the direct lateral approach group(9)




• In a RCT comparing patients who underwent primary THA using a DAA or the direct lateral approach, there was

no significant difference between groups in terms of the mean length of stay (p=0.56). The mean (range) length

of stay was 3.56 (3-5) days in the DAA group and 3.50 (3-6) days in the direct lateral approach group(10)







approaches (2)

23




transgluteal approach, there was no significant difference between groups in terms of the mean length of

stay (p value reported as not significant). The mean (range) length of stay was reported as 10 (7-12) days

in the DAA group and 12 (9-14) days in the lateral transgluteal approach group(11)

Prospective

analysis (Croatia)






• In a prospective analysis comparing patients who underwent THA using either the anterior supine intermuscular

approach or the modified Hardinge approach, there was no significant difference between groups in terms of the

mean length of stay (p>0.1). The anterior supine intermuscular approach was associated with a mean length of

stay of 1.9 days and the modified Hardinge approach was associated with a mean length of stay of 2 days(21)


(USA)


primary THA using either the anterior

supine intermuscular approach


approach (n=77)



(2.3 days) compared with those who underwent THA using the posterolateral approach (2.7 days) (p=0.0004)(23)





• The mean length of hospital stay was significantly lower in patients who underwent primary THA using

the DAA with a modern fracture table (2.28 days) compared with those who underwent THA using the

posterolateral approach (3.02 days) (p=0.0374)(24)




THA (with a CORAIL stem and a



(n=43) or the posterolateral

approach (n=44)

Length of stay is similar or reduced with DAA compared lateral and posterior

approaches (3)

24




compared with those who underwent THA using the posterior approach, with a mean±SD length of stay of

70±3.3 hours in the DAA group and 97±5.5 hours in the lateral approach group (p<0.001)(17)

Retrospective chart

review (USA)






curve, the DAA following the initial learning curve, or the posterior approach, the mean length of stay was

significantly lower in DAA following the initial learning curve group (2.7 days) compared with the posterior

approach group (3.9 days) (p<0.0001). The mean length of stay was 2.9 days in the DAA during the surgeon’s

learning curve group(18)

Retrospective

review (USA)




subsequent cases), or posterior

approach (n=50)

• In a prospective analysis in patients who underwent THA using either the Hueter, Moor, or Gibson’s approach,

the mean length of stay was 8.91 days in the Hueter approach group, 13.52 days in the Moor approach group,

and 9.87 days in the Gibson approach group(12)

Prospective

analysis (Bosnia

and Herzegovina)


THA using the Hueter (most medial

[n=34]), Moor (n=56), or Gibson’s

posterolateral (n=46) approach

• The mean±SD length of stay was 3.9±1.1 days in patients who underwent primary THA using the anterior

approach compared with 3.3±1.4 days in patients who underwent THA using the posterior approach (p=0.1)(13)

Prospective

analysis (USA)



(n=29) or the posterior approach (n=28)

• In a retrospective analysis comparing patients who underwent THA using one of two minimally invasive

approaches, the DAA was associated mean±SD length of stay of 22.2±1.4 and the mini-posterior approach

was associated with a mean length of stay of 30.4±1.2 days (p=0.003)(14)

Retrospective

analysis (Japan)

N=182 (195 hips); patients with a primary

diagnosis of secondary osteoarthritis

who underwent THA using either the

DAA (n= 99 hips) or the mini-posterior

approach (n=96 hips)

Length of stay is similar or reduced with DAA compared lateral and posterior

approaches (4)

25



• The mean length of stay associated with THA using either the DAA or the mini-posterior approach was 2.2 days

(p>0.2 between groups)(54)

Prospective

analysis (USA)

N=222 (hips); patients who underwent

using either the DAA (126 hips) or the

mini-posterior approach (96 hips)


approach, there was no significant difference between groups in terms of the mean length of stay (p=0.1).

The mean length of stay was 3.05 days in the DAA group and 3.2 days in the posterior approach group(16)

Prospective

comparative

study (USA)




DAA (using a standard operating table

and a table-mounted femoral elevator)

(n=60) or the posterior approach

(n=60)


approaches (5)

26

Length of stay is generally 3-5 days, with times as low as 1.7 days reported (1)



• In a retrospective analysis of patients who underwent primary THA using the single incision anterior approach,

the mean±SD length of stay was 3.6±2.4 days(44)

Retrospective

observational study

(USA)



anterior approach

• In a prospective analysis of 100 primary THAs using the Smith-Peterson DAA with a HANA traction table, the

mean (range) length of stay was 2.4 (1-5) days(26)

Prospective review

(USA)



Peterson DAA


the mean (range) length of stay was 1.7 (1-12) days(27)

Retrospective


reported)




approach


the mean (range) length of stay was 1.7 (1-12) days(28)

Retrospective

analysis (USA)




• In a prospective analysis of 500 patients who underwent primary THA using the Smith-Peterson DAA with

a traction table (ProFX or HANA), the median length of stay was 3 days(29)

Prospective

analysis (USA)


primary THA using the Smith-

Peterson DAA with a ProFX or a

HANA traction table

• In a retrospective analysis of patients who underwent bilateral THA using the anterior approach with a

Judet or ProFX table, the mean (range) length of stay was 4 (2-14) days(36)

Prospective

analysis (USA)




or ProFX table

27



• In a retrospective analysis of patients who underwent primary THA using the single-incision anterior

approach with a Judet or ProFX table, the mean length of stay was 3 days in those undergoing unilateral

THA and 5 days in those undergoing bilateral THA(37)

Retrospective

analysis (USA)


primary THA using the single-

incision anterior approach with a

Judet or ProFX table

• The median (range) length of stay was 4 (2-46) days in patients who underwent primary THA using the

anterior approach(38)

Retrospective

analysis (USA)



approach with a Judet or ProFX

table

• The mean length of stay in patients who underwent THA using the anterior approach was 2.56 days(40) Prospective analysis

(USA)



approach

• The mean length of stay in patients who underwent THA using the DAA was 2.3 days(42) Retrospective

analysis (USA)


using the DAA

• The mean (range) length of stay in patients who underwent primary THA using the anterior approach with

an OSI Profix table was 3.2 (1-18) days(49)

Retrospective

analysis (USA)



anterior approach with an OSI

Profix table

Length of stay is generally 3-5 days, with times as low as 1.7 days reported (2)

28


Non-comparative evidence

• In a retrospective review of primary THAs conducted using the DAA, the mean±SD hospital stay was

6.4±1.6 days(55)


(Belgium)

N=300; primary THAs using a DAA

with a positioning table

• In a retrospective analysis of 100 patients who underwent primary THA using the DAA with a leg-positioner Rotex

table, the mean hospital stay was 8 days(31)

Retrospective


reported)

N=100; patients (main diagnosis was


THA using the DAA with a leg-

positioner Rotex table

• In a retrospective analysis of 903 patients who underwent THA using the anterior approach, the mean length of

stay was 8.3 days, including a pre-operative evaluation day(32)

Retrospective

analysis (USA)



anterior approach

• In a RCT including patients who underwent THA using the DAA, the mean±SD (range) hospital stay was

5.4±1.0 (4-7) days in the no drain group, 6.6±1.0 (5-9) days in the closed suction drain group, and

6.7±1.4 (5-9) days in the retransfusion system group(47)

RCT (Switzerland) N=120; patients with osteoarthritis who


extension-distraction table (AMIS

mobile leg positioner) and either no

drain (n=40), a closed suction 3.5 mm

drain connected to a vacuumed

(−900 mbar) drainage bottle (n=40), or an ABTrans autologous retransfusion

system (n=40)

• In a retrospective analysis of patients who underwent THA using the anterior approach, the mean hospital stay

was 12.8 days for unilateral procedures and 22.3 days for sequential procedures (usually performed 7-10 days

apart)(35)

Retrospective

analysis (USA)


or revision THA using the anterior

approach

Contradictory evidence: Length of stay is generally 3-5 days, with times as low as

1.7 days reported

29




curve, the DAA following the initial learning curve, or the posterior approach, the mean length of stay was

significantly lower in DAA following the initial learning curve group (2.7 days) compared with the posterior

approach group (3.9 days) (p<0.0001). The mean length of stay was 2.9 days in the DAA during the surgeon’s

learning curve group(18)

Retrospective

review (USA)




subsequent cases), or posterior

approach (n=50)

Length of stay decreases with surgeon experience of DAA

30

In the European Health Care Systems length of stay is reduced with DAA compared with the lateral approach

Length of stay is similar or reduced with DAA compared with the posterior approach

Length of stay is generally 3-5 days, with times as low as 1.7 days reported

Length of stay decreases with surgeon experience of DAA

Evidence indicates that length of stay can be reduced with DAA compared

with lateral and posterior approaches, and decreases with surgeon

experience of DAA

Value theme 2: Patient value

• Post-operative outcomes






blue

32

Patients show greater improvements in Harris hip scores and WOMAC

scores with DAA compared with other widely-used THA approaches

33

Patients show greater improvements in HHS (from pre-operative HHS) with DAA

compared with lateral or posterior approaches (1)



• In a retrospective review of patients who underwent THA and were prospectively entered into a clinical database,

the mean HHS was similar between groups at baseline (50 in both groups). At 6 weeks, the mean HHS was

significantly higher in the anterior supine intermuscular approach group that the direct lateral approach group (80

vs 75; p=0.0000)(8)

Retrospective

review (country not

reported)






• In a prospective cohort study of patients who underwent primary THA, the minimally invasive approach

was associated with significantly lower mean (range) HHS than the standard lateral transgluteal

approach at 6 weeks (83 [42-100] vs 77 [46-100]; p=0.003), 12 weeks (95 [57-100] vs 91 [44-100]; p=0.009),

and 1 year (99 [73-100] vs 96 [57-100]; p=0.005). At 2 years there was no significant difference between

the minimally invasive approach group and the standard lateral transgluteal approach group in terms of

the mean (range) HHS (99 [56-100] vs 99 [34-100]; p=0.509)(20)

Prospective

cohort study

(Switzerland)





standard lateral transgluteal

approach (n=142)

• In a prospective analysis comparing patients who underwent THA using either the anterior supine intermuscular

approach or the modified Hardinge approach, the anterior supine intermuscular approach was associated with a

significantly higher mean HHS at 6 weeks compared with the modified Hardinge approach (81 vs 75;

p<0.0001)(21)

Prospective

analysis (USA)


THA using either the anterior supine


modified Hardinge approach (n=77)

• In a prospective analysis, the HHS at follow-up was significantly better in the DAA group compared with the

modified Hardinge approach group (92.2±11.9 vs 97.2±4.5; p=0.04)(56)

Prospective

analysis (country

not reported)


underwent THA using either the DAA


approach (n=39)

34



• In a RCT comparing patients who underwent THA using the DAA or the direct lateral approach, the mean HHS at

6 months was 94.6 in the DAA group and 88.6 in the direct lateral approach group (p=0.1)(9)




• In a RCT comparing patients who underwent primary THA using a DAA or the direct lateral approach, mean

(range) HHS for DAA vs direct lateral approach were: 51.86 (34-65.5) vs 54.95 (41.5-63.6) (p=0.06) at baseline,

93.64 (77.1-100) vs 88.8 (65-99.7) (p=0.03) at 6 weeks, and 97.34 (93.0-99.7) vs 97.55 (93.0-99.7) (p=0.72) at

2 years(10)






• In a prospective analysis, the mean HHS was significantly higher in the DAA group compared with the lateral

transgluteal approach group at 2 months (80.2 vs 69.4; p<0.01) and non-significantly higher in the DAA group

compared with the lateral transgluteal approach group at 4 months (92.4 vs 88.1; p=NS)(11)

Prospective

analysis (Croatia)


using either the DAA with a standard

orthopaedic table with a leg holder

(n=35) or the lateral transgluteal

approach (n=35)

• In a prospective analysis, mean HHS for the minimally invasive anterior approach vs the direct lateral approach

were: 43.1 vs 43 at baseline, 68.7 vs 58.2 at 2 weeks, 85.3 vs 81.5 at 6 weeks, 91.9 vs 90.2 at 3 months, and

96.7 vs 93.9 at 6 months(57)

Prospective

analysis (country

not reported)


using the minimally invasive anterior

approach (n=30) or the direct lateral

approach (n=30)



35



• In a RCT comparing THA using the DAA with THA using the posterolateral approach, the HHS was higher in the

DAA group than the posterolateral group, 1 month postoperatively (p<0.03)(23)





• In a RCT comparing THA using the DAA with THA using the posterolateral approach, the mean±SD HHS

for the DAA group vs the posterolateral group was: 57.6±10.2 vs 55.1±9.1 (p=0.2464) at baseline,

89.5±8.1 vs 81.4±9.8 (p=0.0001) at 6 weeks, 91.2±9.7 vs 91.4±9.7 (p=0.9317) at 3 months, 95.8±7.8 vs

95.9±6.8 (p=0.9680) at 6 months, and 97.5±5.7 vs 97.3±5.5 (p=0.8700) at 12 months(24)

RCT (USA) N=87; patients with non-inflammatory

degenerative joint disease who

underwent primary THA (with a

CORAIL stem and PINNACLE cup)

using the DAA with a modern

fracture table and a C-arm (n=43) or


• In a RCT comparing patients who underwent THA using the DAA or the mini-incision posterior approach, 1-year

HHS function scores trended towards significance favouring the DAA (p=0.07)(58)


using the DAA or the mini-incision

posterior approach

• In a prospective analysis of patients who underwent THA using the DAA or the mini-posterior approach, the HHA

was higher in the DAA group compared with the mini-posterior approach group at 8 weeks (95 and 89,

respectively)(54)

Prospective

analysis (USA)





approach, mean±SD HHS for DAA vs posterior approach were: 49.4±7.5 vs 46.6±11.5 (p=0.17) at

baseline, 69±13 vs 64±9.4 (p=0.09) at 2 weeks, 83±12 vs 80±11 (p=0.13) at 6 weeks, 89±10 vs 88±10

(p=0.29) at 12 weeks, and 89±11 vs 91±10 (p=0.59) at 1 year(16)

Prospective

comparative study

(USA)







approach (n=60)



36

Patients report significantly better post-operative WOMAC scores at 6 weeks with

DAA compared with the lateral approach



• In a RCT comparing patients who underwent primary THA using a DAA or the direct lateral approach, mean

(range) WOMAC scores for DAA vs direct lateral approach were: 8.68 (6-12) vs 8.33 (6-11) (p=0.29) at baseline,

4.40 (0-19) vs 9.70 (0-40) (p=0) at 6 weeks, and 2.24 (0-8) vs 1.90 (0-8) (p=0.6) at 2 years(10)






• In a RCT comparing patients who underwent THA using the DAA or the direct lateral approach, the mean

WOMAC score at 6 months was 4.1 in the DAA group and 11.1 in the direct lateral approach group (p=0.1)(9)




37

Patients report similar post-operative WOMAC scores with DAA compared with

anterolateral and posterior approaches



• In a RCT comparing patients who underwent THA using either the DAA or the anterolateral approach, there were

no significant differences between groups in terms of median WOMAC scores (including pain, stiffness and

function scores) at baseline, 6 weeks, and 12 weeks(6)


THA using either the DAA (n=16) or the

anterolateral approach (n=17)


• In a RCT comparing patients who underwent THA using the DAA or the mini-incision posterior approach, 3-week

WOMAC scores trended towards significance favouring the DAA (p=0.08)(58)


using the DAA or the mini-incision

posterior approach

38

Additional publications reporting HHS and WOMAC scores for DAA


Evidence comparing DAA with non-DAA approaches (not reported)

• In a prospective analysis, patients who underwent THA using the DAA had significantly better HHS at 6 weeks

than patients who underwent THA using a non-DAA (p<0.0001)(59)

Prospective

analysis (country

not reported)


using either the DAA (n=185) or a non-

DAA (n=185)

• In a prospective analysis of 100 patients who underwent THA using the anterior supine intermuscular approach,

the mean HHS score was 44 at baseline and 80 at 2-year follow-up. The results of historical data (from the same

surgeon) for patients who underwent THA using a standard approach were reported to be similar(60)

Prospective

analysis (USA)


using the anterior supine intermuscular

approach (compared with historical data

for patients who underwent THA using a

standard approach [n=not reported])


• In a retrospective analysis of patients who underwent THA using the DAA, the mean±SD HSS improved

significantly from 43.6±12 at baseline to 88.2±14 at 35 months (p<0.01). At 35-month follow-up, 66.3% of

patients had excellent score, 18.9% had good scores, 9.5% had fair scores, and 5.3% had poor scores(61)

Retrospective

analysis (Germany)


using the DAA with head sizes ≥36 mm


approach, mean±SD pain scores were: 75.11±19.820 at baseline, 96.62±3.114 at 3 months, 90.44±12.177 at

6 months, 91.31±12.989 at 1 year, 93.07±8.354 at 2 years, and 93.31±1.926 at 3 years. Mean±SD function

scores were: 45.27±12.112 at baseline, 88.14±9.888 at 3 months, 83.40±15.268 at 6 months, 83.43±14.737

at 1 year, 82.02±13.406 at 2 years, and 77.33±6.477 at 3 years(44)

Retrospective

observational study

(USA)



anterior approach

39

Patients show significant or greater improvements in HHS (from pre-operative HHS) with DAA compared with lateral or posterior approaches

Patients report significantly better post-operative WOMAC scores at 6 weeks with DAA compared with the lateral approach

Patients report better WOMAC with DAA compared with a posterior approach

Patients report similar WOMAC scores with DAA compared with anterolateral approaches

Patients show greater improvements in Harris hip scores and WOMAC

scores with DAA compared with other widely-used THA approaches

40

Patients generally show better post-operative walking ability with DAA

compared with anterolateral, lateral, or posterior approaches

41

Patients generally show better post-operative walking ability with DAA compared

with compared with anterolateral, lateral, and posterior approaches (1) Supporting evidence Study details and patient population


• In a RCT comparing patients who underwent THA using either the DAA or the anterolateral approach, there was a

significant increase in median (IQR) 9 m walkway walking speed in the DAA group at 12 weeks post-operatively

(74.80 [61.88-87.25] pre-operatively vs 93.45 [76.25-109.50] at 12 weeks; p=0.003). This increase was not significant

in the anterolateral approach group (79.00 [69.50-106.00] pre-operatively vs 87.00 [83.70-90.50] at 12 weeks;

p=0.319). There was also a significant increase in median cadence (steps/minute) from pre-operation to 12 weeks in

the DAA group (p=0.005) but not in the anterolateral approach group (p=0.335)(6)


THA using either the DAA (n=16) or the

anterolateral approach (n=17)

• In a prospective analysis, mean±SD self-selected velocities (m/minute) at 6 weeks and 3 months, respectively, were

62.30±6.60 and 71.50±7.90 in the anterolateral group, 54.60±9.80 and 63.80±10.80 in the anterior group,

61.40±13.00 and 69.10±11.90 in the posterior standard group, and 66.50±13.50 and 69.20±11.10 in the posterior

minimally invasive group. Mean±SD cadences (steps/minute) at 6 weeks and 3 months, respectively, were

99.00±16.00 and 112.00±12.00 in the anterolateral group, 100.0±14.00 and 108.00±11.00 in the anterior group,

106.00±20.00 and 116.00±14.00 in the posterior standard group, and 108.00±12.00 and 114.00±10.00 in the

posterior minimally invasive group(62)

Prospective

analysis

(country not

reported)

N=69; patients who underwent THA using

either the anterolateral minimally invasive

surgery approach (n=11), the anterior

minimally invasive surgery approach

(n=10), the posterior standard approach

(n=18), or the posterior minimally invasive

approach (n=30)



transgluteal approach, the mean±SD time taken to be able to walk 150 feet (46 m) was 1.87±0.68 days in the

DAA group and 2.42±0.73 days in the lateral transgluteal approach group (p=0.001). At 2 days post-

operatively, 50 patients (83%) in the DAA group and 28 patients (47%) in the posterior approach group could

walk 150 feet(16)

Prospective

analysis

(Croatia)


using either the DAA with a standard

orthopaedic table with a leg holder

(n=35) or the lateral transgluteal

approach (n=35)

42



• In a RCT comparing THA using the DAA with THA using the posterolateral approach, patients in the DAA

group walked further post-operatively than patients in the posterolateral approach group on the day of

surgery (mean±SD: 44.6±28.3 m vs 17.7±23.1 m; p=0.0003), on the first day post-operatively (mean±SD:

173.6±83.8 m vs 121.1±89.8 m; p=0.0062), and on the second day post-operatively (mean±SD:

271.7±88.5 m vs 162.7±80.5 m; p=0.0030). Significantly more patients in the DAA group were walking

unlimited and using stairs normally at 6 weeks post-operatively than in the posterolateral approach group

(p=0.0011)(24)

RCT (USA) N=87; patients with non-inflammatory

degenerative joint disease who

underwent primary THA (with a CORAIL

stem and PINNACLE cup) using the

DAA with a modern fracture table and a

C-arm (n=43) or posterolateral

approach (n=44)

• In a retrospective analysis comparing patients who underwent THA using the DAA or mini-posterior approach,

mean±SE pre-operative 50 m walking time was similar between groups (69.0±5.5 vs 68.7±7.8 seconds,

respectively; p=0.523). At 3 weeks post-operatively, the DAA was associated with a significantly lower mean±SE

50 m walking time compared with the mini-posterior approach (52.3±40.0 vs 74.5±6.3 seconds; p=0.017)(14)

Retrospective

analysis

(Japan)

N=182 (195 hips); patients with a primary

diagnosis of secondary osteoarthritis who

underwent THA using either the DAA (n=

99 hips) or the mini-posterior approach

(n=96 hips)

• In a retrospective chart review of distance walked at physical therapy sessions, in physiotherapy sessions 3 and 4

(when the majority of patients cleared discharge requirements), patients in the DAA group walked significantly further

(mean±SD: 176±12 feet and 182±20 feet in sessions 3 and 4, respectively) compared with patients in the posterior

approach group (mean±SD: 128±12 feet and 117±15 feet in sessions 3 and 4, respectively) (p<0.05). No

significant difference was reported between groups at physiotherapy sessions 1, 2, 5, 6, and 7-12(17)

Retrospective

chart review

(USA)






with compared with anterolateral, lateral, and posterior approaches (2)

43



• In a prospective analysis of patients who underwent THA using the DAA or the mini-posterior approach, there

was no difference in the maximum feet walked in hospital (p>0.2)(54)

Prospective

analysis (USA)




• In a RCT, walking speed increased significantly during the follow-up period in both the minimally invasive surgery

anterior approach group and the conventional posterior approach group (p<0.001 for 6 weeks-3 months,

3-6 months, and 6 weeks-6 months). There was no significant difference in walking speed between the minimally

invasive surgery anterior approach group and the conventional posterior approach group (p=0.79). Cadence was

also comparable between the 2 groups (p=0.06)(63)

RCT

(The Netherlands)


THA using either the computer navigate

minimally invasive surgery anterior

approach (n=35), the conventional

posterolateral approach (n=40), or

healthy controls (n=30)

• In a prospective analysis, mean±SD self-selected velocities (m/minute) at 6 weeks and 3 months, respectively,

were 62.30±6.60 and 71.50±7.90 in the anterolateral group, 54.60±9.80 and 63.80±10.80 in the anterior

group, 61.40±13.00 and 69.10±11.90 in the posterior standard group, and 66.50±13.50 and 69.20±11.10 in

the posterior minimally invasive group. Mean±SD cadences (steps/minute) at 6 weeks and 3 months,

respectively, were 99.00±16.00 and 112.00±12.00 in the anterolateral group, 100.0±14.00 and 108.00±11.00

in the anterior group, 106.00±20.00 and 116.00±14.00 in the posterior standard group, and 108.00±12.00 and

114.00±10.00 in the posterior minimally invasive group(62)

Prospective

analysis (country

not reported)


using either the anterolateral minimally

invasive surgery approach (n=11), the

anterior minimally invasive surgery

approach (n=10) the posterior standard

approach (n=18), or the posterior

minimally invasive approach (n=30)


with compared with anterolateral, lateral, and posterior approaches (3)

44

Patients may discard assistive walking devices sooner with DAA compared with

the posterior approach



• In a RCT comparing patients who underwent THA using the DAA or the mini-incision posterior approach, the time

to discard assistive device was 22.8 days in the DAA group and 35.1 days in the posterior approach group

(p=0.04)(58)


using the DAA (n=185) or the mini-

incision posterior approach (n=185)


approach, the mean±SD time for which patients used walkers/crutches was 14±8 days in the DAA

group and 14±9 days in the posterior approach group (p=0.76). The mean±SD time for which patients

used a cane was 30±16 days in the DAA group and 31±19 days in the posterior approach group

(p=0.72)(16)

Prospective

comparative study

(USA)







approach (n=60)

45

Patients may discard assistive walking devices sooner with DAA compared with the posterior approach

Patients generally show better post-operative walking ability with DAA

compared with anterolateral, lateral, or posterior approaches

46

Compared with other THA approaches, DAA may reduce post-operative

pain

47




curve, the DAA following the initial learning curve (DAA group), or the posterior approach, pre-operative

mean±SD VAS scores were similar between groups (8.2±1.9, 8.0±1.5, and 7.6±2.1, respectively). At 2 weeks

and 6 weeks, the DAA group had lower mean±SD VAS scores (significant at 2 weeks) than the posterior

approach group (2.2 [1.9] vs 5.2 [2.5]; p<0.0001 and 1.4 [2.6] vs 2.6 [2.7]; p=0.2510). In the DAA learning curve

group, the mean±SD VAS score was 2.7 (2.9) at 2 weeks and 2.2 (2.8) at 6 weeks(18)


(USA); pain reported

as mean VAS score




subsequent cases), the posterior

approach (n=50)

• In a RCT comparing THA using the DAA with THA using the posterior approach, pain medication was

significantly lower in the DAA group compared with the posterior groups during hospital stay (p<0.05)(23)





• In a RCT comparing THA using the DAA with THA using the posterolateral approach, there were no

significant differences between treatment groups in terms of HHS and VAS pain scores at 6 weeks, 3

months, 6 months, or 12 months. However, the VAS pain score was significantly lower in the DAA group

vs the posterolateral approach group on the first day after surgery (p=0.0472)(24)




THA (with a CORAIL stem and



(n=43) or posterolateral approach

(n=44)

• In a prospective analysis comparing THA using the DAA with THA using the posterior approach, groin

pain was reported in 4 patients in the DAA group and 2 patients in the posterior group. The mean VAS

score at 48 hours post-operatively was 3.3 in the DAA group and 3.5 in the posterior approach group

(p=0.52)(16)

Prospective

comparative study

(USA); pain

reported as mean

VAS score







approach (n=60)

Patients may have reduced post-operative pain scores with DAA vs the posterior

approach

48



• DAA was associated with a significantly higher maximum VAS pain than the mini-posterior approach (5.3±2 vs

3.8±2; p<0.0001)(54)


(USA)




Contradictory evidence: Patients may have reduced post-operative pain scores

with DAA vs the posterior approach

49



• In a prospective cohort study of patients who underwent primary THA, the minimally invasive approach

was associated with significantly lower median (range) VAS pain scores than the standard lateral

transgluteal approach at 6 weeks (1.0 [1-8] vs 1.5 [0-8]; p=0.003), 12 weeks (0.0 [0-8] vs 1.0 [0-8]; p=0.010),

and 1 year (0.0 [0-8.8] vs 0.0 [0-7.2]; p=0.040). At 2 years there was no significant difference between the

minimally invasive approach group and the standard lateral transgluteal approach group in terms of the

median (range) VAS score (0.0 [0-5] vs 0.0 [0-10]; p=0.403)(20)

Prospective cohort

study (Switzerland);

pain reported as

median VAS score




standard trauma table (n=113) or

the standard lateral transgluteal

approach (n=142)

• In a study that used patient questionnaires to assess pain experienced during hospitalisation, overall pain

remembered by patient and pain during movement were significantly lower in DAA group compared with the

modified Hardinge approach group (2.4 [SD 1.2] vs 1.9 [0.9]; p=0.04, and 2.6 [2.3] vs 1.7 [2]; p=0.05)(56)






approach (n=39)

• In a retrospective analysis, the mean NRS score on the first post-operative day was 1.4 in patients who

underwent THA using the DAA and 2.5 in patients who underwent THA using the lateral approach(19)

Retrospective

analysis (Italy); pain

reported as NRS

score






transgluteal approach, 1 patient reported knee pain in the DAA group and pain was not reported in the

lateral transgluteal group(11)

Prospective

analysis (Croatia)






Patients may have reduced post-operative pain scores with DAA vs the lateral

approach

50



• * Patients in the DAA group showed significantly lower pain than the Bauer approach group during physiotherapy

exercise on Day 1 after surgery (p=0.013). However, during the following days, the DAA group had higher mean

pain levels than the Bauer approach group, with statistically significant differences at Days 3 (p=0.013), 6

(p=0.017), 7 (p=0.005), 8 (p=0.002), and 9 (p=0.001)(51)

Retrospective

analysis (Germany)




approach (n=100)

• In a prospective analysis, mean EQ-VAS for the minimally invasive anterior approach vs the direct lateral

approach were: 41.1 vs 55.6 at baseline, 72.5 vs 67.8 at 2 weeks, 85.9 vs 80.6 at 6 weeks, 87.8 vs 84 at

3 months, and 92.4 vs 91.3 at 6 months(57)




using the minimally invasive anterior

approach (n=30) or the direct lateral

approach (n=30)

Contradictory evidence: Patients may have reduced post-operative pain scores

with DAA vs the lateral approach

This study clearly states that the post-op pain for patients with DAA was lower on day 1 and higher on the following days.

However, the hospital initiated a full weight bearing program with the DAA group vs. 20 kg max. in the control group; which

according to the authors may have been the reason behind this finding (the increase in pain within the DAA group).

51



• In a study that used patient questionnaires to assess pain experienced during hospitalisation, overall pain

remembered by patient and pain during movement were significantly lower in DAA group compared with the

modified Hardinge approach group (2.4 [SD 1.2] vs 1.9 [0.9]; p=0.04, and 2.6 [2.3] vs 1.7 [2]; p=0.05)(56)






approach (n=39)

• Patients in the DAA group showed significantly lower pain than the Bauer approach group during physiotherapy

exercise on Day 1 after surgery (p=0.013). However, during the following days, the DAA group had higher mean

pain levels that the Bauer approach group, with statistically significant differences at Days 3 (p=0.013), 6

(p=0.017), 7 (p=0.005), 8 (p=0.002), and 9 (p=0.001)(51)

Retrospective

analysis (Germany)




approach (n=100)

With DAA vs the lateral approach, patients report significantly lower pain during

hospitalisation, as well as significantly lower pain on Day 1 after surgery

Although the Goebel et al, 2012 reference supports this value message, it may be considered to be unfavourable for DAA as

higher mean pain levels were reported at subsequent time points. However, this study reports a positive impact of DAA on time

to recovery and length of stay

52

Additional publications reporting pain


Evidence comparing DAA with a non-DAA approach (not reported)

• In a prospective analysis, patients who underwent THA using the DAA had significantly less pain than patients

who underwent THA using a non-DAA (p<0.0001)(59)

Prospective

analysis (country

not reported)


using either the DAA (n=185) or a non-

DAA (n=185)



approach, 9 patients (0.8%) reported pain(44)

Retrospective

observational study

(USA)



anterior approach

• In a prospective analysis of 100 primary THAs using the Smith-Peterson DAA with a HANA traction table,

4 patients (4%) reported thigh numbness, which was clinically insignificant at the 3 month visit(26)

Prospective

review (USA)



Peterson DAA

• In a RCT including patients who underwent THA using the DAA, mean±SD VAS scores on Day 1 post-operation

were 2.1±1.7, 1.4±1.9, and 1.2±1.59 in the no drain, closed suction drain, and retransfusion system groups,

respectively. These scores were reduced on Day 2 (1.4±2.3, 1±1.5, and 0.7±1.2 in the no drain, closed suction

drain, and retransfusion system groups, respectively) and were 0.7±1.2 in all groups on Day 3(47)

RCT (Switzerland);

pain was reported

as mean VAS score



extension-distraction table (AMIS mobile

leg positioner) and either no drain

(n=40), a closed suction 3.5 mm drain

connected to a vacuumed (−900 mbar) drainage bottle (n=40), or an ABTrans

autologous retransfusion system (n=40)

53

Evidence shows that patients may have reduced post-operative pain scores with DAA vs the posterior.

With DAA vs the lateral approach, patients report significantly lower pain during hospitalisation.

Compared with other THA approaches, DAA may reduce post-operative

pain

Value theme 3: Long-term value

• Revision rates






blue

55

Revision rates for DAA are low and comparable with other widely-used THA

approaches

56


approaches (1)



• In a retrospective comparative study, no revisions were reported in 16 months in patients who underwent

THA using the DAA and 1 revision (0.3%) was reported in 30 months in patients who underwent THA

using the posterior approach. In those patients forming part of the DAA learning curve, 2 revisions were

reported in 22 months(25)

Retrospective

comparative study

(USA)



(n=286), the posterior approach

with a standard operating table and

table-mounted femoral elevator,

and with fluoroscopy (n=293), or

those forming part of the DAA

learning curve (n=96)

Evidence comparing DAA with a standard THA approach (not reported)

• In a prospective analysis of 100 patients who underwent THA using the anterior supine intermuscular approach,

3 revisions (3%) were reported in 2 years. The revision rate reported was similar to the revision rate observed

using historical data (from the same surgeon) for patients who underwent THA using a standard approach(60)


(USA)



intermuscular approach (compared

with historical data for patients who

underwent THA using a standard

approach [number not reported])


• In a retrospective analysis of 956 primary or revision THAs using the anterior supine intermuscular approach, 16

revisions (1.6% incidence) were reported at 40 months follow-up, including 6 periprosthetic femur fractures,

1 stem subsidence, 2 acetabular failures, 3 dislocations, and 3 infections(53)


(USA)

N=956; consecutive primary (n=956)

and revision (n=44) THA using the


approach

57



• In a retrospective analysis of 906 patients who underwent THA (1,035 THA) using the anterior supine

intermuscular approach, 25 revisions (2.4% incidence of THA revision) were reported at up to 56 months follow-

up(27)

Retrospective


reported)




approach

• In a retrospective analysis of 824 patients who underwent THA (935 THAs) using the anterior supine

intermuscular approach, 21 revisions (2.2% incidence of THA revision) were reported at up to 73 months follow-

up(28)

Retrospective

analysis (USA)




• In a retrospective analysis of 709 patients who underwent primary THA using the DAA, 13 revisions (1.8%

incidence of THA revision) were reported in 3.5 years.(64)

Retrospective

analysis (USA)

N=709; patients with arthritis who


• In a retrospective analysis of 147 patients who underwent bilateral THA using the anterior approach with

a Judet or ProFX table, no revisions were reported at 1 year(36)

Prospective

analysis (USA)




or ProFX table

• In a retrospective analysis of 247 primary THAs using the anterior approach with an OSI Profix table,

3 reoperations (1.2%) and 3 revisions (1.2%) were reported in 8.4 months(49)

Retrospective

analysis (USA)



anterior approach with an OSI

Profix table


approaches (2)

58


approaches

59

Value of CORAIL/PINNACLE

• Overview of evidence

• Value theme 1: Inpatient value

• Value theme 2: Patient value

• Value theme 3: Long-term value

60

Value theme 1: Inpatient value

• Theatre time

• Length of stay

Studies reporting evidence in favour of DAA

are outlined in green. However, all studies

are non-comparative and good outcomes

are defined as per notes section

61

Duration of surgery is within a normal range in patients undergoing THA

with CORAIL/PINNACLE, regardless of surgical approach

Length of hospital stay is within a normal range in patients undergoing THA


62

Duration of surgery is generally 60-90 minutes in patients undergoing THA with

CORAIL/PINNACLE


• In a RCT of patients with a BMI <30 kg/m2 who received unilateral THA with a CORAIL stem and PINNACLE cup

using a transgluteal lateral approach (Bauer [n=42]) or a minimally invasive approach (MicroHip [n=36]), both

THA approaches were associated with acceptable theatre time (mean ± SD: 66±27 minutes using the

transgluteal lateral approach and 55±15 minutes using the minimally invasive approach).(1) Theatre times were

higher but acceptable in patients with a BMI ≥30 kg/m2: 70±28 minutes using the transgluteal lateral approach

(n=41) and 60±9 minutes using the minimally invasive approach (n=15)(65)

Prospective RCT

(Germany);

mean±SD surgery

time reported by BMI

group

N=134; patients undergoing unilateral

THA with a CORAIL stem and a

PINNACLE cup

• In a prospective cohort study, the mean duration of surgery in patients undergoing THA with a CORAIL stem and

a PINNACLE cup was 59 minutes (range: 34-112 minutes)(66)

Prospective, single

centre cohort study

(UK)

N=316; patients undergoing THA with

a CORAIL stem and a PINNACLE cup

63

Evidence Study details and patient population

• The mean operative time in patients undergoing primary THA with either a CORAIL or a different cementless

stem and a PINNACLE cup was 110 minutes (range: 64-183 minutes)(67)

Retrospective

analysis of

prospectively

collected data (UK)

N=54 undergoing primary THA (61

hips) with either a CORAIL or a

different cementless stem and a

PINNACLE cup

Contradictory evidence: Duration of surgery is generally 60-90 minutes in patients

undergoing THA with CORAIL/PINNACLE

64


• In a prospective cohort study, the median post-operative length of stay in patients undergoing THA with a

CORAIL stem and a PINNACLE cup was 3 days (range: 1-49 days)(66)

Prospective, single

centre cohort study

(UK)

N=316 undergoing THA with a


• In a retrospective analysis of prospectively collected data, the mean length of hospital stay in patients undergoing

primary THA with either a CORAIL or a different cementless stem and a PINNACLE cup was 3.85 days (range:

2-13 days). The patient with a 13 day length of stay had a history of chronic obstructive pulmonary disease and

was admitted to the ICU post-operatively due to aspiration pneumonia(67)

Retrospective

analysis of

prospectively

collected data (UK)

N=54 undergoing primary THA (61

hips) with either a CORAIL or a

different cementless stem and a

PINNACLE cup

• In a prospective analysis, the mean length of stay in patients who received THA with a CORAIL stem and a

PINNACLE cup was 1.99 nights (range: 1-19 nights)(68)


of patients included in

a short stay THA

programme (England

and Wales)

N=100 who underwent THA with a


Length of hospital stay is generally 3-5 days in patients undergoing THA with

CORAIL/PINNACLE

65

Evidence Study details and patient population

• In patients with a BMI <30 kg/m2 who received unilateral THA with a CORAIL stem and PINNACLE cup using a

transgluteal lateral approach (Bauer [n=42]) or a minimally invasive approach (MicroHip [n=36]), the mean±SD

number of days to discharge was 9±2 days and 8±1 days, respectively.(1) Similarly, in patients with a BMI score

≥30kg/m2, the mean±SD number of days to discharge was 9±2 days in both the transgluteal lateral approach

group (n=41) and the minimally invasive approach group (n=15)(65)

Prospective RCT

(Germany);

mean±SD days to

discharge reported by

BMI group



PINNACLE cup

Contradictory evidence: Length of hospital stay is generally 3-5 days in patients

undergoing THA with CORAIL/PINNACLE

66

Duration of surgery is generally 60-90 minutes in patients undergoing THA with CORAIL/PINNACLE

Duration of surgery is within a normal range in patients undergoing THA


Length of hospital stay is generally 3-5 days in patients undergoing THA with CORAIL/PINNACLE

Length of hospital stay is within a normal range in patients undergoing THA


67

Value theme 2: Patient Value

• Post-operative outcomes

Studies reporting evidence in favour of DAA are

outlined in green. However, all studies are non-

comparative. Good outcomes are therefore

defined in the notes section

68

Patients who undergo THA with CORAIL/PINNACLE show significant

improvements from pre-operation in composite scores assessing pain,

function, deformity, stiffness, and range of motion

69

Patients who undergo THA with CORAIL/PINNACLE show dramatic improvements

in HHS from pre-operation to 1 and 2 years post-operatively


• In a prospective cohort study including 28 patients undergoing THA with a CORAIL stem and a PINNACLE cup,

the mean total HHS score (median±SD) improved dramatically, increasing from 35±11 pre-operatively to

91±13 at 1 year post-operatively and 92±14 at 2 years post-operatively (no p-values were reported)(69)

Prospective cohort

study (Australia)

N=28; patients undergoing THA with a


<70%=poor (−), 70-80=fair (0), 80-90=good (+), 90-100=excellent (+)

70

Significant improvements in pre-operative HHS and OHS are observed in patients

who undergo THA with CORAIL/PINNACLE, regardless of BMI (1) Supporting evidence Study details and patient population

Evidence reporting HHS

• In patients with a BMI score <30 kg/m2 who underwent THA with a CORAIL stem and a PINNACLE cup using a

transgluteal lateral approach (Bauer [n=42]) or a minimally invasive approach (MicroHip [n=36]), there were

significant improvements (p<0.001) in the mean HHS from baseline (pre-operation) (48±15 and 46±16,

respectively) to 3 months post-operation (84±18 and 88±16, respectively).(3) Similarly, in patients with a BMI

score ≥30 kg/m2, the mean HHS improved significantly (p<0.001) from baseline to 3 months, increasing from

44±15 to 88±12 in the transgluteal lateral approach group (n=41) and from 46±16 to 88±11 in the minimally

invasive approach group (n=15)(65)

Prospective RCT

(Germany);

mean±SD HHS

reported by BMI

group



PINNACLE cup

<70%=poor (−), 70-80=fair (0), 80-90=good (+), 90-100=excellent (+)

Evidence reporting OHS using the current scoring system

• In patients with a BMI score <30 kg/m2 who underwent THA with a CORAIL stem and a PINNACLE cup using a

transgluteal lateral approach (Bauer [n=42]) or a minimally invasive approach (MicroHip [n=36]), there were

significant improvements (p<0.001) in the mean OHS from baseline (pre-operation) (20±8 and 21±8,

respectively) to 3 months post-operation (39±10 and 42±6, respectively).(1) Similarly, in patients with a BMI

score ≥30 kg/m2, the mean OHS improved significantly (p<0.001) from baseline to 3 months , increasing from

19±8 to 18±7 in the transgluteal lateral approach group (n=41) and from 41±6 to 43±5 in the minimally

invasive approach group (n=15)(65)

Prospective RCT

(Germany);

mean±SD OHS

reported by BMI

group



PINNACLE cup

• In a prospective RCT in which patients underwent THA using a CORAIL stem (with a ceramic femoral head) and

PINNACLE cup, the mean OHS improved significantly (p-values not reported) from pre-operation to 12 months

post-operation: the mean pre-operative OHS was 18 (range: 4-33) and the mean 12 month post-operative OHS

was 42 (range: 15-48)(70)

Prospective RCT

(New Zealand)

N=41; patients with osteoarthritis

undergoing THA with a CORAIL stem

and a PINNACLE cup randomised to

receive a ceramic femoral head

OHS scores <27=poor (−), 27-33=fair (0), 34-41=good (+), >41=excellent (+)

71


Evidence reporting OHS using a previous scoring system

• In 316 patients who underwent THA with a CORAIL stem and a PINNACLE cup, the mean OHS score decreased

(indicating a reduction in difficulties†) from 49.5 (95% CI: 48.9, 50.1) pre-operatively to 26.5 (95% CI: 25.7, 27.3)

6 weeks post-operatively(66)

Prospective, single

centre cohort study

(UK)

N=316 undergoing THA with a


† This publication reports data using a previous version of the OHS, which is scored on a scale of 12-60 (best to worst)

Significant improvements in pre-operative HHS and OHS are observed in patients

who undergo THA with CORAIL/PINNACLE, regardless of BMI (2)

72

Significant improvements across all domains (pain, stiffness, and physical function) of pre-

operative WOMAC scores are observed in patients who undergo THA with CORAIL/PINNACLE


• In a prospective RCT in which patients underwent THA using a CORAIL stem (with a ceramic femoral head) and

PINNACLE cup, the mean WOMAC improved significantly (p-values not reported) from pre-operation to 12

months post-operation: the mean pre-operative WOMAC was 38 (range: 11-36) and the mean 12 month post-

operative WOMAC was 83 (range: 33-96)(70)

Prospective RCT

(New Zealand)

N=41; patients with osteoarthritis

undergoing THA with a CORAIL stem

and a PINNACLE cup randomised to

receive a ceramic femoral head

• In 316 patients who underwent THA with a CORAIL stem and a PINNACLE cup, there were significant

improvements (p-values not reported) from pre-operation to 6 weeks post-operation in WOMAC across 3

domains:(66)

o For pain, the mean WOMAC was 14.0 (95% CI: 13.6, 14.4) pre-operatively and 4.4 (95% CI: 4.0-4.8) at 6

weeks post-operatively

o For stiffness, the mean WOMAC was 5.7 (95% CI: 5.5, 5.9) pre-operatively and 2.7 (95% CI: 2.5-2.9) at 6

weeks post-operatively

o For physical function, the mean WOMAC was 51.4 (95% CI: 50.4, 52.4) pre-operatively and 23.5 (95% CI:

21.9-25.1) at 6 weeks post-operatively

Prospective, single

centre cohort study

(UK)

N=316; patients undergoing THA with

a CORAIL stem and a PINNACLE cup

† In the Schouten et al, 2012 publication, increased WOMAC indicated an improvement whereas, in the Hunt et al, 2009 publication, higher scores indicated greater impairment

73

Additional publications reporting HHS and OHS


Evidence reporting HHS

• In a retrospective analysis of patients who underwent primary THA, the mean±SD HHS was 95.4±7.1 (95% CI:

96.6, 98) at the latest follow-up (mean, 3.8 years; range, 2.1-5.4 years)(71)

Retrospective

analysis (Austria)

N=60 hips (58 patients); patients who

underwent primary THA with CORAIL

(n=49) or other cementless stems

(n=11) and PINNACLE cups

† <70%=poor (−), 70-80=fair (0), 80-90=good (+), 90-100=excellent (+)

Evidence reporting OHS using the current scoring system

• In patients who were followed and questioned regarding OHS after THA using a CORAIL stem and a PINNACLE

cup, the median OHS reported was 47 (IQR: 41-48) at a median follow-up of 38 months (IQR: 32-53)(72)

Prospective study

(UK)

N=103 identified from a site

arthroplasty database who had

undergone THA using a CORAIL stem

and a PINNACLE cup

† OHS scores <27=poor (−), 27-33=fair (0), 34-41=good (+), >41=excellent (+)

Evidence reporting OHS using a previous scoring system

• In a prospective patient database analysis reporting survival of the stem (CORAIL) and cup (83% PINNACLE) at

3 years following THA, the average 3-year OHS was 12 (indicating the lowest level of difficulty†)(73)

Prospective database

analysis (UK)

N=751; THA cases using a CORAIL

stem (version modified in 2004 with

increased neck taper). A PINNACLE

cup was used in 83% of cases (17%

not reported)

† This publication reports data using a previous version of the OHS, which is scored on a scale of 12-60 (best to worst)

74

Patients who undergo THA with CORAIL/PINNACLE show notable improvements in HHS from pre-operation to 1 and 2 years post-operatively

Significant improvements in pre-operative HHS and OHS are observed in patients who undergo THA with CORAIL/PINNACLE, regardless of BMI

Significant improvements across all domains (pain, stiffness, and physical function) of pre-operative WOMAC scores are observed in patients who undergo THA with CORAIL/PINNACLE

Patients who undergo THA with CORAIL/PINNACLE show significant

improvements from pre-operation in composite scores assessing pain,

function, deformity, stiffness, and range of motion

75

Value theme 3: Long-term value

• Revision rates/survivorship

• Radiographic outcomes

Studies reporting evidence in favour of DAA are

outlined in green. However, all studies are non-

comparative. Good outcomes are therefore

defined in the notes section

76

Long-term outcomes are good with CORAIL/PINNACLE, with low revision

rates and low incidence of stem subsidence and cup migration

77

Cumulative revision rates are low in patients who undergo THA with

CORAIL/PINNACLE and survivorship is generally ≥95% at 10 years (1) Supporting evidence Study details and patient population

Evidence from peer reviewed literature

• In a study conducted to establish revision rate, reoperation rate, patient reported functional outcomes, health

measures, and satisfaction in patients who had undergone THA with a CORAIL stem and PINNACLE cup, one

revision was reported at 98 months, resulting in a survivorship for revision of 99.0% (95% CI: 93.2, 99.9)(72)

Prospective study

(UK)

N=103 identified from a site

arthroplasty database who had

undergone THA using a CORAIL stem

and a PINNACLE cup

• In a prospective patient database analysis reporting survival of the stem (CORAIL) and cup (83% PINNACLE) at

3 years following THA, overall survival was 99.5%. Survival of the stem at 3 years was 99.9%, with 1 case of

periprosthetic fracture following a fall. Survival of the cup at 3 years and was 99.6%(73)


analysis (UK)

N=751 THA cases using the CORAIL


increased neck taper). PINNACLE cup

was used in 83% of cases (17% not

reported)

• In a retrospective analysis using data reported by the NJR for 35,386 THA procedures using a CORAIL stem and

a PINNACLE cup conducted in patients with a primary diagnosis of osteoarthritis, the overall rate of revision rate

at 5 years was 2.41% (99% CI: 2.02, 2.79). The cumulative revision rate was 1.77% (99% CI: 1.53, 2.01) at 3

years and 0.79% (99% CI: 0.66, 0.93) at 1 year(74)

Retrospective cohort

study (UK)

N=35,386 procedures in patients with

osteoarthritis in the NJR (301 sites)

who underwent THA using a CORAIL

stem and a PINNACLE cup

Guidance from the National Institute of Health and Care Excellence (NICE) states that prostheses for THA should only be

recommended as treatment options if prostheses have rates (or projected rates) of revision ≤5% at 10 years.(3) However, the

available evidence does not always provide 10 year revision rates/survivorship

78


Evidence from registry data

• In 26,938 primary, conventional THA cases using a CORAIL stem and a PINNACLE cup, the Australian

Orthopaedic Association National Joint Replacement Registry reported a cumulative percent revision of 2.5%

(95% CI: 2.3, 2.7) at 3 years, 3.1% (95% CI: 2.9, 3.4) at 5 years, 3.7% (95% CI: 3.3, 4.0) at 7 years, and 5.4%

(95% CI: 4.5, 6.5) at 10 years(75)

Registry report

(Australia)

N=26,938; THA cases using a

CORAIL stem and PINNACLE cup

• In 4,596 primary THA cases using a CORAIL stem and a PINNACLE cup, the New Zealand Joint Registry

reported a revision rate of 0.74 per 100 component years (95% CI: 0.61, 0.88)(76)

Registry report

(New Zealand)

N=4,596; THA cases using a CORAIL

stem and PINNACLE cup

• In 1,988 THA cases using a CORAIL stem and a PINNACLE cup from 2003-2011, the Slovak Arthroplasty

Register reported a revision rate of 0.60(77)

Registry report

(Slovakia)



• In 4,453 THA cases using a CORAIL stem and a PINNACLE cup, the Danish Arthroplasty Register reported

survivorship of 95.6% (95% CI: 94.6-96.6) at 5 years(78)

Registry report

(Denmark)



Cumulative revision rates are low in patients who undergo THA with

CORAIL/PINNACLE and survivorship is generally ≥95% at 10 years (2)

Guidance from the National Institute of Health and Care Excellence (NICE) states that prostheses for THA should only be

recommended as treatment options if prostheses have rates (or projected rates) of revision ≤5% at 10 years.(3) However, the

available evidence does not always provide 10 year revision rates/survivorship

79


Evidence from registry data

• In 95,702 THA cases using a CORAIL stem and a PINNACLE cup, the National Joint Registry (NJR) of England,

Wales, and Northern Ireland reported a cumulative percentage probability of revision of 2.89% (95% CI: 2.75,

3.03) at 5 years, 4.75% (95% CI: 4.51, 5.00) at 7 years, and 7.94% (95% CI: 7.10, 8.88) at 10 years(79)

Registry report

(England, Wales, and

Northern Ireland)

N=95,702; THA cases using a

CORAIL stem and PINNACLE cup

Contradictory evidence: Cumulative revision rates are low in patients who undergo

THA with CORAIL/PINNACLE and survivorship is generally ≥95% at 10 years

80

Clinically significant stem subsidence (≥3 mm) is not observed in patients who undergo THA using a CORAIL stem


Evidence for stem subsidence

• In 36 patients who underwent elective THA using a CORAIL collarless stem and a PINNACLE cup, mean femoral

stem subsidence at 6-12 months post-operation was 1.57 mm (range: 0-5.5 mm)(80)

Retrospective

analysis (UK)


underwent THA with a CORAIL stem

and a PINNACLE cup

• In a prospective patient database analysis of 751 THA cases, all using a CORAIL stem and 83% using a

PINNACLE cup, subsidence of the CORAIL stem had occurred in 0.3% of cases at 3 years(73)


analysis (UK)

N=751; THA cases using a CORAIL


increased neck taper). A PINNACLE

cup was used in 83% of cases (17%

not reported)

• In a prospective cohort study in patients undergoing THA using a CORAIL stem and PINNACLE cup, mean stem

subsidence at 6 years was 0.63 mm (range: −0.33 mm to 3.68 mm). Only 4 stems (of the 27 hips analysed) subsided >0.1 mm between 6 months and 6 years, and 3 stems subsided >0.1 mm between 2 years and 6 years.

For all stems, additional subsidence after 6 months was <0.25 mm. The mean subsidence between 2 and 6

years was therefore 0.03 mm (below the limit measurable using RadioStereometric Analysis)(81)

Prospective cohort

study (Australia)

N=30 (27 analysed); patients with

osteoarthritis undergoing THA with a


81

Few cases of clinically significant cup migration are observed with the PINNACLE

cup and, in cases of early cup migration >1 mm, migration curves generally flatten

down rapidly after 3 months


Evidence for cup migration

• In a retrospective analysis of patients who underwent primary THA, migration curves could be applied for 57 of

60 cases using PINNACLE cups. Within the first 3 months, clinically significant cup migration of >1 mm was

reported in 8 of these 57 cases.(71) The authors reported that further analyses of migration patterns provided

reassurance that these results were not of concern due to the following:(71)

o Migration curves flattened down rapidly after the third postoperative month, indicating that osseointegration

of the porocoat surface of the Pinnacle cup may have occurred

o Of the 8 cups that migrated >1 mm within the first 3 months, 7 reached a plateau phase or a lower, but

nearly curvilinear migration by 12 months

o Only 2 cups of the whole cohort showed constantly increasing, linear migration patterns and were in need of

close clinical and radiological follow-up

Retrospective

analysis (Austria)

N=60 hips (58 patients); patients who

underwent primary THA with CORAIL

(n=49) or a different cementless stem

(n=11) stems and PINNACLE cups

82

Cumulative revision rates are low in patients who undergo THA with CORAIL/PINNACLE and survivorship is generally ≥95% at 10 years

Clinically significant stem subsidence (≥3 mm) is not observed in patients who undergo THA using a CORAIL stem

Few cases of clinically significant cup migration are observed with the PINNACLE

cup and, in cases of early cup migration >1 mm, migration curves generally flatten down rapidly after 3 months

Long-term outcomes are good with CORAIL/PINNACLE, with low revision

rates and low incidence of stem subsidence and cup migration

83

Mean length of stay is significantly lower in patients who undergo THA using DAA with a modern fracture table and C-arm fluoroscopy (2.28 days) vs the posterolateral approach (3.02 days) (p=0.0374)(24)

Length of hospital stay is low or normal in patients who undergo DAA with a traction table (HANA, Judet, or ProFX), with reported median lengths of stay of 2–3 days, and reported mean lengths of stay of 3–3.2 days for unilateral THA and 4–5 days for bilateral THA(29, 36-

38, 49)

In the short term, low revision rates have been reported in patients who undergo THA using DAA with a traction table (Judet, ProFX, or OSI Profix)(36, 49)

Duration of surgery is generally within a normal range of 60–90 in patients undergoing THA using DAA with a traction table (HANA, Rotex, ProFX, or Judet , with theatre times as low as 53 minutes reported (HANA table)(36-38, 26, 29-31)

Value messaging for the traction table and fluoroscopy

84

Appendices for DAA

• Systematic review

methodology

• PRISMA flow diagram for

DAA

85

Systematic review methodology

• Databases (Embase, MEDLINE, the Cochrane Library) were searched on 11th April 2014. Reference lists of included

studies, clinical trial registries, recent 2011-2014 topical conference proceedings, and topical orthopaedic registries

were searched manually

• Two additional publications were later identified in a published systematic review(82) and included

• Patient population included: individuals undergoing THA surgery (primary or revision) using the anterior approach

• Interventions included: the anterior approach with or without using a bespoke surgical table (with or without a C-

arm)

• Comparators included: alternative surgical approaches for THA

• Outcomes included:

o Efficacy/effectiveness: maintaining stability, returning to normal mobility, mobility of limbs, weak/impaired gait,

more rapid recovery, hip function and gait ability, component positioning, cup placement

o Safety and reliability: dislocation rate, cement leakage, leg length discrepancy, infection rate, intraoperative

fracture rate, heterotopic ossification, intraoperative blood loss, post-operative adverse events, muscle damage,

nerve damage, learning curve

o Costs and resource use: length of hospital stay, learning curve, increased patient volume, reduced resource

utilisation (any outcome)

o Quality of life: any patient reported outcomes and patient satiisfaction, including but not limited to: HHS, OHS,

WOMAC, SF-12, SF-36, EQ-5D, range of motion

86

Systematic review methodology ctd.

• Study designs included: study design was not restricted. Single case studies, editorials, reviews, news and letters

were excluded as well as publications not in the English language

• Additional inclusion criteria at 2nd pass: following consensus among the entire project team, Mr Anil Gambhir and

other surgeons, including Dr Joel Matta, DePuy Synthes confirmed to only include level I and II studies (see quality

assessment criteria below) and those level III and IV studies with ≥75 patients (or hips if only number of hips reported) who underwent DAA

• Quality assessment criteria: publications were assessed for their level of evidence and graded according to the

following criteria(83)

o Level I: High quality RCTs

o Level II: Lesser quality RCTs or prospective comparative studies

o Level III: Case-control studies or retrospective comparative studies

o Level IV: Case series

o Level V: Expert opinion

87

PRISMA flow diagram for DAA

Database searches: 1,522

Embase: 906

MEDLINE: 501

Cochrane library: 145

Duplicates: 384

Abstracts screened (1st pass): 1,168 Excluded on:

Title/abstract: 998

Disease/indication: 372

Intervention: 269

Language (not English): 161

Review: 110

Study design: 57

Patient population: 26

Animal/in vitro study: 3 Screened by full paper (2nd pass): 170

Excluded on full paper: 106

Total included: 92

53 full publications

39 abstracts

Hand searches: 28

88

Appendices for CORAIL/PINNACLE

• Systematic review

methodology

• Flow diagrams of CORAIL

and PINNACLE systematic

reviews

89

Systematic review methodology

• The systematic review was conducted in stages:

o Stage 1: previous systematic reviews conducted by DePuy Synthes, which used broad inclusion criteria to find all

relevant papers, were reviewed to identify eligible publications

o Stage 2: updated searches were conducted on 12th June 2013 for the CORAIL publications and on 5th June 2013

for the PINNACLE publications to identify relevant publications published between October 2012 and June 2013.

Identified publications were reviewed for inclusion in the systematic review

o Stage 3: additional hand searches were reviewed for inclusion in the systematic review. Searches were also

conducted on 20th August 2015 to update registry data included in the systematic review

• The systematic review included any publication reporting on the CORAIL stem or PINNACLE cup together or in any

combination with other acetabular cups of femoral stems. However, the evidence presented here focuses on studies

that report on the CORAIL stem and PINNACLE cup together

• Outcomes of interest: crude rate of revision, survivorship/CRR, OHS, HHS, WOMAC, pain, stem subsidence, cup

migration, length of hospital stay

90

Flow diagrams for CORAIL and PINNACLE

systematic reviews

Identified from

previous SRs: 32

Identified through

QUOSA search: 39

Excluded: 13 Excluded: 27

Total included from

previous SRs: 19

Total included from

QUOSA search: 12

Conference

searches: 7

Final included publications: 38

Of which CORAIL/PINNACLE hip system:

15

Identified from

previous SRs: 28

Identified through

QUOSA search: 48

Excluded: 17 Excluded: 31

Total included from

previous SRs: 11

Total included from

QUOSA search: 17

Conference

searches: 6

Final included publications: 34

Of which CORAIL/PINNACLE hip system:

15

CORAIL flow diagram PINNACLE flow diagram

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