prior authorization review panel mco policy submission a ......cartiva synthetic cartilage implant,...

Prior Authorization Review Panel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date:11/01/2019

Policy Number: 0708 Effective Date: Revision Date:10/04/2019

Policy Name: Metatarsal Phalangeal Joint Replacement

Type of Submission – Check all that apply:

New Policy

Revised Policy* Annual Review – No Revisions Statewide PDL

*All revisions to the policy must be highlighted using track changes throughout the document. Please

provide any clarifying information for the policy below:

CPB 0708 Metatarsal Phalangeal Joint Replacement

This CPB has been revised to state that the Arthrex metatarsal phalangeal joint implant is considered experimental and investigational.

Name of Authorized Individual (Please t ype or print):

Dr. Bernard Lewin, M.D.

Signature o f Authorized Individual:

Proprietary Revised July 22, 2019

Proprietary

(https://www.aetna.com/)

Metatarsal Phalangeal Joint Replacement

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Number: 0708

*Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Aetna considers the following procedures medically necessary for persons with disabling arthritis

of the first metatarsal phalangeal joint (hallux rigidus): (i) total prosthetic replacement

arthroplasty with silastic implants; and (ii) hemiarthroplasty.

Aetna considers metatarsal phalangeal joint replacement for other indications, and for joints

other than the first metatarsal phalangeal joint (e.g., tarsal metatarsal joint) experimental and

investigational because its value is unproven.

Aetna considers ceramic prostheses (e.g., the Moje implant) experimental and investigational for

replacement of the first metatarsal phalangeal joint and for other indications because their long-

term effectiveness has not been established.

Aetna considers modular implants (e.g., the Arthrex metatarsal phalangeal joint implant, the

Cartiva Synthetic Cartilage Implant, the METIS prosthesis, the OsteoMed ReFlexion 1st MTP

Implant System, and the ToeFit-Plus prosthesis) experimental and investigational for

replacement of the first metatarsal phalangeal joint and for other indications because their long-

term effectiveness has not been established.

Last Review

10/05/2019

Effective: 10/28/2005

Next

Review: 07/24/2020

Review

History

Definitions

Additional

Clinical Policy

Bulletin

Notes

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Aetna considers interpositional arthroplasty with biologic spacers (e.g., the InterPhlex interdigital

implant) and total prosthetic replacement arthroplasty using total metallic implants experimental

and investigational for hallux rigidus, degenerative arthritis, and other indications involving the

metatarsal phalangeal joints because their effectiveness has not been established.

See also CPB 0629 - Bunionectomy (../600_699/0629.html).

Most clinical presentations of the hallux (big toe) concern the metatarsal phalangeal joint (MPJ).

The underlying causes of disease/disorder of the MPJ include osteoarthritis, rheumatoid arthritis,

disease of the hallucal sesamoids and post-traumatic degeneration. Both types of arthritis often

affect the first MPJ located at the base of the big toe. The MPJ may become stiff (hallux rigidus),

or deformed (hallux valgus). Hallux rigidus is characterized by pain as well as a reduction in the

range of motion (ROM), especially dorsiflexion, at the first MPJ. Hallux valgus is classified as an

abnormal deviation of the great toe towards the midline of the foot. Disease/disorder of the MPJ

affects shoe wear, ambulation, and other activities of daily living. Although the literature

addressing treatments of conditions that affect the hallux often focuses on surgical interventions,

the use of conservative therapies is emphasized before surgery is considered. Conservative

treatments include exercise, physiotherapy, supportive shoes worn alone or worn with soft/semi-

rigid orthoses, non-steroidal anti-inflammatory drugs, and steroid injections. Many surgical

procedures have been described for the treatment of congenital and acquired conditions of the

big toe. They include arthrodesis (fusion of the joint), arthroplasty, cheilectomy (trimming of the

joint), Keller procedure (simple excision of the joint), osteotomy, and plantar release. Metatarsal

phalangeal arthrodesis remains the gold standard for arthritis and salvage of the painful first MPJ

(Weinfeld and Schon, 1998; Giannnini et al, 2004; Sammarco and Nichols, 2005; Kelikian,

2005).

Brage and Ball (2002) stated that when approaching patients with a painful first MPJ that has

failed conservative therapies and first-line surgical treatments (cheilectomy or minor bunion

procedures), the surgeon should stratify these patients based upon diagnosis, age, and activity

level. For the young, active patient, an arthrodesis is the gold standard, and the primary

predictors of clinical and radiographical success are proper fusion angle alignment and

maintenance or restoration of length. In the elderly, inactive patient, arthrodesis is a safe and

reliable treatment option. However, the Keller procedure may be preferable because it provides

excellent early symptomatic relief and has a less debilitating post-operative rehabilitation

program. The patients between these two extremes fall into a treatment gray zone. The




arthrodesis should again be considered the gold standard because it is reliable and durable with

time and activity. However, the authors noted that biologic or prosthetic inter-positional

arthroplasty are exciting investigational treatment options for these patients. If a prosthetic

implant is to be used, the double-stemmed, hinged silastic implant with protective titanium

grommets, or a metallic hemi-arthroplasty prosthesis, appear to be the 2 best choices of

implant. With the continuous advances in material engineering and tissue engineering,

prosthetic and biologic inter-positional arthroplasties hold the greatest promise for the painful first

MPJ in the future. These treatment modalities allow restoration of alignment and maintenance of

motion, length, and strength, which are fundamental in attaining a good clinical result. The

authors stated that when the optimal material is developed (whether it is prosthetic, biologic, or a

combination of both), these treatment advantages will be realized without the attendant

complications associated with the use of the current implants. The observations of Brage and

Ball (2002) were in agreement with those of Sizensky (2004).

Coughlin and Schurnas (2004) reported their experience with cheilectomy or MPJ arthrodesis in

the treatment of hallux rigidus. Of the original 114 patients with a diagnosis of hallux rigidus, 110

returned for the final evaluation. Eighty patients (93 feet) had undergone a cheilectomy, and 30

patients (34 feet) had had an arthrodesis. The mean durations of follow-up were 9.6 and 6.7

years following cheilectomies and arthrodeses, respectively. These authors reported that 97 %

of patients (107/110) had a good or excellent subjective result, and 92 % of cheilectomy (86/93)

were successful in terms of pain relief and function. Cheilectomy was used with predictable

success to treat grade-1, grade- 2 and selected grade-3 cases. Patients with grade-4 hallux

rigidus or grade-3 hallux rigidus with less than 50 % of the metatarsal head cartilage remaining

at the time of surgery should be treated with arthrodesis.

A systematic evidence review of treatments for hallux rigidis by Yee and Lau (2008) found that

the consistently favorable results reported in several level IV studies constituted fair evidence

(grade B recommendation) to support the use of cheilectomy in persons with grade I and II hallux

rigidis. The authors noted that 2 separate studies observed poor results in a small subset of

patients with advanced degeneration of the MPJ. The authors concluded that, based on this

evidence, cheilectomy can not be recommended for grade III hallux rigidus.

Taylor et al (2004) stated that arthrodesis has emerged as the primary salvage procedure for

severe osteoarthritis of the first MPJ. These investigators reported that 43 patients underwent

arthrodesis of the first MPJ with stabilization provided by either 2 crossed lag-screws or a dorsal

plate and screws. First MPJ arthrodesis was the primary procedure for 46 of the 54 treated feet.

At a mean of 21.7 months (median of 13.5 months), 34 of the 43 patients completed a brief

telephone survey about surgical outcomes. Radiographical measurements of inter-metatarsal,

hallux valgus, inclination, and dorsiflexion angles were made pre-operatively and post-



operatively. Mean time to fusion was 7.3 weeks; arthrodesis was successful for 50 of 52 feet

(radiographs were missing for 2 of the 54 feet treated). Internal fixation devices were removed

from 5 feet. Thirty of the 34 patients (88.2 %) rated their result as excellent or good; the other 4

(11.8 %) rated their result as poor.

A systematic evidence review by Yee and Lau (2008) found that the consistently favorable

results in many level II and IV studies constitute fair evidence (grade B recommendation) to

support the use of arthrodesis for the treatment of stage III hallux rigidus.

Although joint replacement remains the ultimate solution for hip osteoarthritis, and may be a

viable option in ankle osteoarthritis, replacement of the MPJ has not been established as a

standard of care for osteoarthritis of the hallux. Despite its initial success in relieving symptoms,

the use of total joint replacements of the first MPJ with a flexible hinged silicone prosthesis for

replacement arthroplasty was initially abandoned because of the high and increasing rate of

failure of the implant, as demonstrated radiographically (Granberry et al, 1991). These first

generation silastic implants failed because of the high shear forces concentrated at the

prosthetic hinge.

To address this, new systems were redesigned for insertion with titanium grommets to reduce

the stress applied to the silastic in order to increase the survival of the arthroplasty (Yee and Lau,

2008). Sebold et al (1996) investigated the use of double-stem silicone implants protected by

titanium grommets. These were placed in the hallux metatarso-phalangeal joints of 32 patients

(47 feet). All patients had a painful destroyed joint and most were women. Three patients (6

feet) were lost to follow-up. Nineteen patients had a diagnosis of rheumatoid arthritis (25 feet)

and 10 had degenerative joint disease (16 feet). The average age for the group was 57 years

and the average follow-up was 51 months (range of 34 to 76 months). Twenty patients (30 feet)

were completely satisfied with their result. Eight patients (10 feet), all with rheumatoid arthritis,

had some minor post-operative complaints, usually involving the lateral toes. Two patients (3

feet) in this group had no pain, but would have preferred more hallux motion. One patient with

rheumatoid arthritis (1 foot) had a poor result due to implant removal for deep sepsis.

Radiographical analysis of these patients showed no evidence of implant fracture and the

implant composite appeared to be well-tolerated by the surrounding bone in which it was placed.

The investigators reported that, when compared with another, similar group of patients in whom

grommets were not used, this implant appeared to be much more stable, as there was

significantly less evidence of radiolucency seen around those implants protected by the

grommets. The investigators stated that the titanium grommets may protect the silicone implant

and may help provide a longer life for the silicone implant.



In a systematic evidence review of treatments for hallux rigidus, Yee and Lau (2008) stated that,

despite these improvements, concerns persist regarding the potential effects of silicone debris

leading to foreign-body reaction, synovitis, and bone erosion in the hallux. In addition, the

systemic effects of silicone microfragments invading the lymphoreticular system are still

unknown. The authors concluded that conflicting evidence weakly supports total prosthetic

replacement arthroplasty with silastic implants with hallux rigidus (grade C recommendation).

Other MPJ prostheses include the titanium hemi-great toe implant (Leavitt et al, 1991), the 2-

component first MPJ implant (Gerbert et al, 1995), and the Moje press-fit ceramic implant

(Malviya et al, 2004). Malviya et al reviewed their results with the Moje press-fit ceramic

implant. This study included 7 procedures in 6 patients with a mean age of 60.2 years followed

for a mean of 35 months (a range of 24 to 43 months). There was a significant (p < 0.001)

improvement of the visual analog score from 7-8 to 1-2 and of the Foot Function Index from 75.6

to 8.6. A mean post-operative dorsiflexion of 29.2 degrees and plantar flexion of 12.1 degrees

were recoded. Apart from slight cortical recession in 1 case, probably related to overuse, there

was little evidence of osteolysis or loosening of implants and no major complication has been

noted in any of the patients. The authors stated that the press-fit design appears to have

overcome the disadvantages of the previous screw-fit prosthesis that had been reported to have

complications related to metallosis around the titanium screw.

The Clinical Practice Guideline First Metatarsophalangeal Joint Disorders Panel (Vanore et al,

2003) noted that total joint replacement systems have been designed for the first MPJ generally

as 2-component non-constrained articulations in an attempt to allow motion in more than 1

plane. Materials used for opposing articular surfaces are chosen for their low coefficient of

friction and for their minimum wear characteristics. Numerous implant systems have been

developed during the years, and several are still used clinically, although long-term clinical

usefulness has yet to be established. The panel stated that judicious use and strict criteria are

recommended to avoid complications and problematic revisions.

The National Institute for Health and Clinical Excellence (NICE, 2005a) released an assessment

on MPJ replacement of the hallux. It concluded that available evidence on the safety and

effectiveness of MPJ replacement of the hallux appears adequate to support the use of this

procedure, but there is limited evidence of the durability of this procedure. The NICE

assessment stated that clinicians should ensure that patients fully understand the uncertainties

about the place of this procedure in relation to alternative treatment options such as arthrodesis

(NICE, 2005a). The assessment stated that patient selection is important, and should take into

consideration the likely intensity and duration of use of the joint based on the patient's activities

and aspirations. This report also stated that further research will be useful in establishing the

long-term outcomes of different types of prostheses. These conclusions were based on a review



of the available evidence (NICE, 2005b). The main outcome measures reported were pain relief

and patient satisfaction. Three studies reported that 73 % (8/11), 79 % (46/58) and 100 % (7/7)

of joints with implants were pain-free after mean follow-ups of 17 months, 12 years, and 35

months, respectively. Another study including 86 implants reported a statistically significant

improvement in pain scores after the procedure. Two further studies reported pain relief in 66 %

(59/90) of implants and 94 % (30/32) of patients (mean follow-ups of 3 years and 8 years,

respectively). Four studies reported that between 74 % (29/39) and 88 % (7/8) of patients were

completely satisfied with the procedure (mean follow-ups of 12 months and 17 months,

respectively). Although most of the specialist advisors to NICE stated that this was an

established technique, these advisors noted that there is limited evidence on the durability of the

newer implants. The specialist advisors also stated that potential adverse events included

persistent pain, infection, implant loosening, implant fracture, osteolysis, bone over-production,

cyst formation, silastic granulomas, and transfer metatarsalgia. Some of these complications

may require removal of the joint. Radiological follow-up may show fracture of prostheses or

immobility of joints in the long-term. However, the influence of these changes on symptom relief

remains unclear.

On the other hand, some recent reviews did not find MPJ replacement to be a standard

treatment for diseases/disorders of the hallux (Fuhrmann et al, 2003; Giannnini et al, 2004;

Ferrari et al, 2004; Wulker, 2004; Keiserman et al, 2005; Esway and Conti, 2005). Fuhrmann et

al (2003) reported their experience with replacement of the first MPJ. After a 3-year follow-up,

most patients who had an MPJ replacement were extremely satisfied with the outcome. Plantar

pressure distribution revealed a marked improvement. However, recovery of

metatarsophalangeal (MTP) dorsiflexion was limited and joint stability worsened. Radiologically,

1/3 of the prostheses showed radiolucent lines indicating loosening of the implant. These

researchers stated that MPJ replacement offers distinct advantages in the treatment of end-

stage hallux rigidus, but more research is needed on implant design and osseous fixation.

A review on surgical interventions for hallux rigidus (Giannnini et al, 2004) did not list MPJ

replacement as one of the options, which include arthrodesis, cheilectomy, Keller procedure,

osteotomy, plantar release, and arthroplasty with the use of a spacer. Additionally, a Cochrane

review on interventions for treating hallux valgus (Ferrari et al, 2004) did not mention the use of

MPJ replacement. Furthermore, Wulker (2004) stated that conservative treatments for hallux

rigidus mainly consist of local anti-inflammatory applications and orthopedic appliances to

decrease load at the MPJ. With progression of the arthrosis, joint-preserving procedures such

as cheilectomy are used. In complete destruction of the joint space, arthrodesis is the technique

of choice in the mostly active, younger patients. The author stated that resection arthroplasty is

mainly used in the elderly, less active patients, and the results of first MPJ replacement are

inferior to arthrodesis.



Keiserman et al (2005) noted that many surgical procedures are available for the treatment of

hallux rigidus. The choice depends on the severity of the disease, activity level of patient, and

expectations about the surgery. These investigators said that cheilectomy is recommended for

early disease and may be associated with an osteotomy of the proximal phalanx. For active

patients who have severe hallux rigidus, arthrodesis and biological inter-position arthroplasties

have shown good results. These investigators stated that Keller arthroplasty is reserved for

patients with low functional demand; and prosthetic replacements are not recommended at this

time. In addition, Esway and Conti (2005) stated that replacement of the hallux MPJ does not

have the same success as hip and knee arthroplasties. Silastic joint implants have a high

patient satisfactory rate; however they have caused many complications, including silicone

synovitis and lymph node inflammation. Metal and polyethylene hemi-arthroplasties and total toe

replacements appear to be more promising although results are preliminary. Problems with

these implants seem to be related to soft tissue instability of the joint; patients who have hallux

rigidus have more success than patients who have hallux valgus or rheumatoid arthritis. Severe

complications can be treated with removal and synovectomy or arthrodesis, depending on the

length and alignment of the foot, as well as the functional demands of the patients. These

researchers further stated that it would be beneficial to have more data on these implants so that

improvements can be made in design and patient selection.

Silastic hemiarthroplasty was initially abandoned as a treatment for hallux rigidus because of

their failure in terms of poor durability, foreign body reaction and dislodgement of components

(Shankar, 1995; Rahman and Fagg, 1993). The metallic hemiarthroplasty was developed in

response to these failures of silastic implants (Townley and Taranow, 1994). The procedure

involves the resection of the proximal portion of the proximal phalanx in addition to the

resection remodeling of the metatarsal head (Townley and Taranow, 1994). The metallic

prosthesis is then implanted to replace the articulating surface of the proximal phalanx. Current

metallic hemiarthroplasty has not been proven to offer significant benefits compared with other

surgical alternatives.

Available published peer-reviewed evidence for metallic hemiarthroplasty consists primarily of

retrospective case series (Townley and Taranow, 1994; Taranow et al, 2005). In the only

prospective study of metallic hemiarthroplasty for hallux rigidus published to date, Roukis and

Townley (2003) reported similar short-term outcomes with metallic hemiarthroplasty and

periarticular osteotomy. The investigators compared metallic hemiarthroplasty to periarticular

osteotomy in 44 patients (47 feet) with hallux rigidus. A subjective evaluation, physical

examination, and radiographical analysis were performed pre-operatively and at a 1-year follow-

up. Twenty patients (20 feet) underwent a peri-articular osteotomy, with 16 patients (16 feet)

returning. Seven patients (9 feet) underwent metallic hemiarthroplasty, with all patients

returning. The subjective evaluation was based on a modified American Orthopaedic Foot and



Ankle Society Hallux Metatarsophalangeal-Interphalangeal 100-point scale. The physical

examination included first MPJ ROM. Radiographical analysis included the metatarsal

protrusion distance, transverse plane angulation of the second digit, lateral talo-first metatarsal

angle, sagittal plane relationship of the first and second metatarsals, and hallux equinus angle.

Statistically significant differences between pre-operative and post-operative values were found

for the periarticular osteotomy group for the metatarsal protrusion distance (p = 0.000),

transverse plane angulation of the second digit (p = 0.000), and lateral talo-first metatarsal angle

(p = 0.015). No other statistically significant differences between the pre-operative and post-

operative values for either procedure group were found to exist. The investigators noted that

there were equally significant improvements in subjective scores and a high percentage of

patient satisfaction in both groups. However, both procedures resulted in only in minimal

increases in first MPJ ROM.

Raikin et al (2007) reported better long-term outcomes with arthrodesis than with metallic

hemiarthroplasty in hallux rigidus. Patients with hallux rigidus were treated with either a metallic

hemiarthroplasty or an arthrodesis between 1999 and 2005. Post-operative satisfaction and

function were graded with use of the American Orthopaedic Foot and Ankle Society Hallux

Metatarsophalangeal Interphalangeal (AOFAS-HMI) scoring system, and pain was scored with

use of a visual analog scale. The investigators reported that 21 hemiarthroplasties and 27

arthrodeses were performed in 46 patients. Five (24 %) of the hemiarthroplasties failed; 1 of

them was revised, and 4 were converted to an arthrodesis. Eight of the feet in which the

hemiprosthesis had survived had evidence of plantar cut-out of the prosthetic stem on the final

follow-up radiographs. At the time of final follow-up (at a mean of 79.4 months), the satisfaction

ratings in the hemiarthroplasty group were good or excellent for 12 feet, fair for 2, and poor or a

failure for 7. The mean pain score was 2.4 of 10. All 27 of the arthrodeses achieved fusion, and

no revisions were required. At the time of final follow-up (at a mean of 30 months), the

satisfaction ratings in this group were good or excellent for 22 feet, fair for 4, and poor for 1. The

mean pain score was 0.7 of 10. Two patients required hardware removal, which was performed

as an office procedure with the use of local anesthesia. The AOFAS-HMI and visual analog pain

scores and satisfaction were significantly better in the arthrodesis group. The investigators

reported that arthrodesis is more predictable than a metallic hemiarthroplasty for alleviating

symptoms and restoring function in patients with severe halluxrigidus.

A systematic evidence review by Yee and Lau (2008) found that, except for a study co-authored

by the developer of the hemiarthroplasty (Townley and Taranow, 1994), the use of

hemiarthroplasty in the management of hallux rigidus is supported by conflicting or poor quality

evidence (grade C recommendation). The long-term consequences for hemiarthroplasties that



have not failed but are malpositioned, subsided or surrounded by radiolucencies remains

uncertain. The authors stated that further studies designed to yield level I or II evidence are

warranted to address these concerns.

In a randomized controlled clinical study, results of arthrodesis were also found to be superior

than total joint replacement with metallic implants. Gibson et al (2005) reported on the results of

a randomized controlled trial to evaluate clinical outcomes after MPJ arthrodesis and

replacement arthroplasty in end-stage hallux rigidus. Between November, 1998, and January

2001, 63 patients between the ages of 34 and 77 years, with unilateral or bilateral MPJ arthritis

were recruited and randomly selected to have either MPJ arthrodesis or arthroplasty. Twenty-

two patients (38 toes) had arthrodesis and 27 patients (39 toes) had arthroplasty. A single

surgeon performed all surgery. The primary outcome measure determining successful surgery

was a decrease in pain as measured on a visual analog scale (VAS). Functional outcome was

assessed at 6 months and 1 and 2 years. The investigators reported that, at 24 months, pain

improved in both groups (p < 0.001), but there were significantly greater improvements after

arthrodesis (p = 0.01). All 38 arthrodeses united at a mean dorsiflexion angle of 26 degrees,

with few complications. In contrast, in the arthroplasty group, 6 of the 39 inserted implants had

to be removed because of phalangeal component loosening. In the remainder the ROM gained

was poor, and the patients tended to bear weight on the outer border of their foot. The

investigators concluded that outcomes after arthrodesis were better than those after

arthroplasty. The investigators reported that the results were partially attributable to an

unacceptably high incidence of loosening of the phalangeal components, which resulted in

removal of the implants. The investigators noted, however, even when data from the failures

were excluded, arthrodesis was clearly preferred by mostpatients.

A systematic review of the evidence for treatment of hallux rigidus by Yee and Lau (2008) found

that given the unfavorable results in multiple studies with different implants, total prosthetic

replacement arthroplasty with metallic implants "cannot be recommended at this time for the

management of hallux rigidus." The authors stated that the results of the prospective,

randomized trial by Gibson et al (2005) constitute a grade B recommendation of arthrodesis

instead of arthroplasty. The authors stated, however, that more level I or II evidence is warranted

to confirm these findings.

Deheer (2006) argued against first MPJ implant arthroplasty. The author noted that

intermediate- and long-term studies raise concerns about implant failure and longevity. Other

causes for concern are silicone-induced synovitis and lymphadenopathy. Furthermore, the lack

of any significant long-term results and the documented metallic breakdown from 2-piece

metallic implants make their use in hallux rigidus questionable. Meanwhile, a comparative study

showed the superiority of arthrodesis to implant arthroplasty. Also, alternatives tojoint-



destructive procedures are emerging. These include arthrodiastasis and the osteochondral

autograft transfer procedure. The author concluded that this evidence proves that implant

arthroplasty is not the best treatment for patients with hallux rigidus or other first MPJ pathology.

Interpositional arthroplasty combines a standard resection arthroplasty with the insertion of a

biologic spacer into the joint to avoid some of the difficulties associated with an isolated resection

arthroplasty. Various tissues, including tendons, have been utilized in the interpositional graft.

Theoretically, this procedure necessitates less bone resection from the proximal phalanx and

better maintains joint stability and motion (Yee and Lau, 2008).

Hamilton et al (1997) reported on their experience with 30 patients (37 feet) with severe hallux

rigidus who underwent interpositional arthroplasty over a 10-year period. The authors reported

that pain and function were significantly improved. The American Orthopaedic Foot and Ankle

Society (AOFAS) scores improved from an average of 23 pre-operatively to 37 post-operatively.

Average dorsiflexion improved from 10 to 50 degrees. Transfer metatarsalgia was not seen. All

patients had at least 4/5 plantarflexion strength and averaged 50 degrees of dorsiflexion. The

authors concluded that, in patients with severe hallux rigidus and nearly equal length of first and

second metatarsals, capsular interposition arthroplasty offers a surgical option that relieves pain

without sacrificing motion or strength.

Kennedy et al (2006) examined 18 patients with severe articular cartilage loss who received 21

interposition arthroplasties. The patients a mean age was 56 years. They had a mean follow-up

of 38 months. All patients had substantial loss of articular cartilage when examined intra-

operatively. Patients were evaluated using the AFOAS and Short Form-36 scores. All 18

patients had pain relief, and 17 of 18 patients said they would have the procedure again. The

mean post-operative increase in ROM of the first MPJ was 37 degrees. The mean AFOAS and

Short Form-36 scores were 78.4 and 96.3, respectively. The complication rate was 6 %.

Lau and Daniels (2001) conducted a retrospective review of 19 patients (24 feet) with grade 2

osteoarthritis and 11 patients (11 feet) with grade 3 osteoarthritis. The patients with grade 2

osteoarthritis were managed with a cheilectomy and the patients with grade 3 osteoarthritis with

an interpositional arthroplasty. All patients were individually assessed with a subjective

questionnaire, physical examination, AOFAS hallux scale, SF-36 and pedobarographic analysis.

Cheilectomy patients (51.9 years) were younger than interpositional arthroplasty (59 years).

Follow-up between the interpositional arthroplasties (2.0 years) and cheilectomies (2.1 years)

were comparable. Post-operative motion, VAS and SF-36 scores were comparable between

groups. Cheilectomies had a higher mean AOFAS score (77.3) than interpositional

arthroplasties (71.6). Weakness of the great toe was reported in 72.7 % of interpositional

arthroplasty patients compared to only 16.7 % of patients with a cheilectomy. Patient satisfaction



was 87.5 % in cheilectomies and 72.7 % in interpositional arthroplasties. Pedobarographic

analysis demonstrated a decreased load under the great toe with increased weight transfer to

the lesser metatarsal heads in all patients. The weight transfer to the lesser metatarsal heads

was greatest in patients with interpositional arthroplasty. The authors concluded that

management of moderate hallux rigidus with a cheilectomy and phalangeal osteotomy is a

reliable method of relieving pain and improving function. Management of severe osteoarthritis

of the joint with an interpositional arthroplasty should be considered a salvage procedure with

less reliable results.

Other studies published of interpositional arthroplasty using a biologic spacer have also been

level IV evidence, including Barca (1997) (12 patients followed for an average of 21 months) as

well as Coughlin and Shurnas (2003) (7 patients followed for an average of 41 months). In a

systematic evidence review of treatments for hallux rigidus, Yee and Lau (2008) concluded that

considering the limited quantity and quality of the data, there is insufficient evidence (grade I

recommendation) to recommend interpositional arthroplasty for the treatment of hallux rigidus.

The Moje ceramic toe implant is made of zirconium oxide and was developed in 1994 by Dieter

Werner (an orthopedic surgeon) and Hans Jurgen Moje (a ceramic engineer). The original

implant was screw-fit but complications of osteolysis and metallosis led to the replacement of the

design with the press-fit one. The press-fit implant is a 2-component ceramic prosthesis coated

with apatite and fosterite crystals (Bioverit). It relies mainly on interference fit coupled with

osseo-integration encouraged by the Bioverit coating. The coating forms a closed contact with

the substrate and possesses a good adhesive strength (Malviya et al, 2004).

In a single-surgeon series study, Barwick and Talkhani (2008) evaluated the clinical outcome of

the Moje arthroplasty using objective and subjective assessment tools. A retrospective outcome

study of 24 implants was performed in 22 patients undergoing first MPJ replacement for

osteoarthritis from 2004 to 2006. Each patient underwent clinical assessment using the AOFAS

for the hallux and a patient outcome satisfaction questionnaire. All pre- and post-operative

radiographs were reviewed. Average follow-up was 26 months with a median AOFAS score of

80 out of a maximum 100. The revision rate at 3 years was 12.5 %. Only 63 % of patients were

"very satisfied" with the overall outcome from the procedure. AOFAS for the hallux correlated

strongly with patient satisfaction. Radiographical mal-alignment in 4 patients was significantly

associated with lower AOFAS (p = 0.01). The authors concluded that the Moje ceramic

prosthesis offers less reliable outcomes than the "gold standard" arthrodesis and caution is

advised regarding its use for osteoarthritis of the first MPJ.



McGraw et al (2010) assessed the mid-term clinical and radiographical results of the Moje hallux

MPJ replacement. These investigators described their single-surgeon experience of 63

components in 48 patients at a mean follow-up of 44 months. Patient satisfaction was assessed

by questionnaire and radiographical assessment performed immediately post-operatively and at

the latest follow-up. Mean AOFAS hallux score increased from 56 to 72 (p < 0.01) and mean

satisfaction score was 7.6 (scale 1 to 10). A total of 67 % of subjects reported minimal or no

pain. Five implants have been removed (8 %), 4 because of pain associated with implant

loosening and subsidence, and 1 because of deep infection. Fifty-seven percent of metatarsal

and 56 % of phalangeal components had subsided and radiographical evidence of loosening in

58 % of X-rays analyzed at latest follow-up was found. Prosthetic subsidence was associated

with greater margin of uncovered bone under the prosthesis (p = 0.05 for metatarsal, p = 0.03 for

proximal phalanx component) and longer follow-up (p < 0.001). The authors concluded that in

spite of the good clinical outcome at the mid-term stage with 91 % implant survival, given the

widespread loosening and subsidence encountered in this study, the long-term outcome

following this procedure is uncertain.

In a case series study, Brewster and colleagues (2010) reported the functional results of

the Moje first MPJ replacements performed between February 2001 and November 2006. All

patients who underwent Moje arthroplasty under the care of a single surgeon were included;

outcome scores and complications were recorded annually. A total of 32 joints in 29 consecutive

patients were followed for a mean duration of 34 (range of 6 to 74) months, and the mean patient

age at the time of operation was 56 (range of 38 to 79) years. Hallux rigidus was the primary

diagnosis in 28 (87.5 %) of the cases. The mean AOFAS-HMI score at final follow-up was

74/100 (range 9 to 100), with 13 (40.63 %) joints rated good-to-excellent. Two (6.25 %) joints

were revised to arthrodesis at a mean of 52 (range of 41 to 63) months following the arthroplasty

procedure, and the overall prevalence of post-operative complications was 6 (18.75 %). Based

on these results, the authors concluded that first MPJ joint replacement with the Moje device

remains promising, but still has room for improvement before the results match those obtained

with larger joint (knee, hip) arthroplasty. Thus, more studies including larger number of patients

with longer follow-up are needed to evaluate the long-term results of the Moje ceramic prosthesis

for MPJ replacements. Furthermore, Gutteck and colleagues (2011) stated that the high

loosening rate of the Moje prosthesis in the treatment of hallux rigidus caused disappointing

medium-term results. Arthrodesis using an iliac crest bone graft is the standard salvage

procedure.

Metatarsophalangeal implants have been proposed as treatment for disorders effecting joints

other than the first MTP joint, for other toe joints (e.g., interphalangeal joints), and for the tarsal

metatarsal (TMT) joint. However, there is insufficient evidence regarding the use of MTP

implants for these indications.



Nagy et al (2014) noted that ceramic first MPJ replacement has been reported for treatment of

hallux rigidus (HR), but there are no published mid- or long-term studies available. These

investigators presented their mid-term results using a 2nd-generation ceramic first MPJ implant.

A retrospective review of clinical data and radiographs was performed for 31 feet (24 women;

mean age at surgery was 55 ± 6 years) who had first MPJ replacement with a 2nd-generation

ceramic prosthesis (primary, 29 feet; revision, 2 feet). Mean follow-up was 81 ± 27 months after

surgery. Mean first MP passive ROM was 32 ± 17 degrees (dorsiflexion and plantarflexion).

Mean AOFAS score was 72 ± 19 points and Foot Function Index was 27 ± 26 points (all 31

feet). Clinical rating for 29 feet that had surgery as a primary procedure was excellent in 5 feet

(17 %), good in 8 feet (28 %), fair in 3 feet (10 %), and poor in 13 feet (45 %). Patients were

satisfied with the outcome in 24 feet (77 %). Follow-up radiographs showed that radiolucency,

change in angulation, sinkage, and mal-alignment of the metatarsal or proximal phalanx

components were common. Complications included 1 superficial wound infection, and revision

was performed in 5 feet (16 %) because of loosening, sinkage, subluxation, pain, or fractured

prosthesis. Implant survival was 92 % at 5 years, 85 % at 7 years, and 68 % at 9 years. The

authors concluded that these findings of 2nd-generation ceramic first MPJ replacement in this

series demonstrated poor clinical and radiological results with a high revision rate.

Stone and colleagues (2017) stated that the optimal operative management of HR is still a

matter for debate among surgeons. Despite arthrodesis widely considered to be the gold

standard treatment, many surgeons advocate arthroplasty as a suitable alternative. There are,

however, few long-term or high-quality studies evaluating these modalities. These researchers

presented the 15-year follow-up of a randomized controlled trial (RCT). These data were the

follow-up to the original study published in 2005. In the original study, 63 patients (77 toes) were

recruited to and randomized to have either metatarsophalangeal joint (MTPJ) arthrodesis or

arthroplasty. The primary outcome measure was a decrease in pain on a (VAS at 24 months. In

the present study, data were available for all surviving patients (52 patients, 66 toes). Data were

collected in the form of satisfaction scores, VAS for pain, the VAS foot and ankle and

survivorship data. The results of the original study demonstrated that pain relief was greater

following arthrodesis at 2 years. At 15 years, patients with an arthrodesis experienced less pain

and were more satisfied compared to those with an arthroplasty. No functional differences were

seen between these 2 groups. There were more revisions in the arthroplasty group. The

authors concluded that despite the hope of better function, less pain, and greater satisfaction

from MTPJ replacement, this was not found in the authors’’ patient population. The long-term

results of this study showed that arthrodesis out-performed arthroplasty. If an arthroplasty failed,

then salvage was likely to be technically difficult, with significant potential for complications.

Level of Evidence = I.

The METIS Prostheses



In a retrospective study, Kolodziej and colleagues (2013) evaluated functional and radiographic

results of the first MPJ replacement with use of unconstrained, modular, 3- component, porous

titanium and hydroxyapatite coated, press-fit METIS® prosthesis. According to author's

knowledge, results of this type of prosthesis have never been published before. A total of 25

prostheses were implanted in 24 patients (were 20 females and 4 males) between February

2009 and May 2011; AOFAS-HMI was used to assess functional results. Patients were also

asked if they would undergo procedure again or recommend it to other people. Weight-bearing

radiographs ware made at final follow-up and analyzed for presence of osteolysis and

radiolucency. In 8 patients total joint replacement was introduced as a salvage treatment after

failure of previous surgery like Keller resection arthroplasty, failed arthrodesis, avascular necrosis

and post-operative arthritis. The reasons for prosthetic replacement were HR (n = 11),

rheumatoid arthritis (n = 4) and gout (n = 1). Additional procedures were performed in 3 cases

(Akin phalangeal osteotomy in 2 cases and fifth metatarsal osteotomy in 1 case). The mean age

at the operation was 56 years. The average follow-up period was 18 months (range of 12 to 36

months). The median post-operative value of AOFAS-HMI scores was 88 points (range of 75 to

95 points). First metatarsophalangeal joint motion (dorsiflexion plus plantarflexion) was

classified according to AOFAS-HMI ranges as: moderately restricted (between 30 to 70 degrees)

in 19 patients 80 % (20 prosthesis) and severely restricted (less than 30 degrees) in 5 patients

(20 %). Overall, 15 (64 %) patients were completely satisfied, 5 (20 %) reported moderate

satisfaction and 4 (16 %) were totally disappointed and would not undergo this procedure again.

A limited hallux dorsiflexion was the main dissatisfaction reason. Partial radiolucent line was

seen in 1 patient (4 %). There were 2 serious complications. In 1 patient, with rheumatoid

arthritis, deep infection occurred 12 months after prosthesis implantation. In the second case

phalangeal implant was revised due to misalignment. The authors concluded that the METIS®

MPJ replacement allowed alleviate of pain relating to HR and partial restoration of joint

movement, even in patients after failures of primary MPJ surgery. AOFAS-HMI results were

better than previously reported in the literature in assessment of the first MPJ replacement.

These preliminary findings need to be validated by well-designed studies.

In a prospective study, Silva and colleagues (2015) evaluated the preliminary results from the

METIS-Newdeal metatarsophalangeal prosthesis for treating hallux rigidus grade III/IV. A total of

8 metatarsophalangeal prostheses that were placed in 6 patients between November 2007 and

July 2009 were included in this report. The patients' mean age was 55 years and the mean

follow-up after the surgery was 50 weeks. The results were evaluated using the AOFAS-MTP

score and x-ray images as controls. The AOFAS-MTP score increased significantly from 42p

before the surgery to 82p after the surgery (↑ 1.95x), mainly due to improvement in the functional

level. No intercurrences were identified radiologically. Among the 5 patients who underwent

operations, only 1 expressed dissatisfaction with the surgery: this was expressed after early

infection appeared at the surgical site, and it was the only post-operative complication found.



The authors concluded that total metatarsophalangeal arthroplasty using METIS-Newdeal

presented promising short-term results. However, they stated that evaluations on a larger

number of cases with a longer follow-up are needed in order to draw more consistent

conclusions.

Dygrynova and associates (2017) evaluated the results of cheilectomy and TJR in patients with

hallux rigidus. Minimum duration of follow-up was 18 months. The study included 59 patients

who underwent surgery due to hallux rigidus between January 2013 and December 2014; 37

patients underwent cheilectomy and 22 patients had total joint arthroplasty using the METIS.

The outcomes were assessed by comparing pre-operative and post-operative ROM, VAS,

AOFAS-HMI and patients' satisfaction with operative treatment. Pre-operative and post-

operative outcomes were compared for the individual types of surgery using the repeated

measures ANOVA. The level of statistical significance was set at p < 0.01. The mean age was

47.9 ± 7.0 years in patients who underwent cheilectomy and 62.5 ± 5.5 years in patients after

TJR METIS. There was a significant decrease (p < 0.001) in the VAS pain score and a

significant improvement in dorsiflexion, ROM, AOFAS-HMI scores in both the treatment groups.

In both the groups more than 75 % of patients reported good or excellent subjective results.

The authors stated that these findings were in agreement with findings of other studies

assessing the results of cheilectomy and TJR surgery in patients with hallux rigidus. Direct

comparison of the VAS pain score, AOFAS-HMI and ROM across studies was difficult because

of variability in the evaluation systems. They stated that cheilectomy is mostly recommended for

young active patients with mild osteoarthritis. Moreover, it is also possible to use minimally

invasive surgery with early and reliable outcomes. These investigators performed cheilectomy

also in younger patients with moderate osteoarthritis in order to extend the period of clinically

acceptable results and thereby to postpone the TJR indication. They stated that TJR (similarly to

arthrodesis of the 1st MTP joint) is a procedure performed in elderly patients with low physical

activity and more advanced deformities. The authors concluded that both the reported methods

offer reliable and valuable short-term clinical outcomes with relatively low complication rate.

They stated that cheilectomy is undoubtedly more appropriate for younger patients with mild or

moderate arthritic changes. Although it did not appear to alter the natural progression of the

disease process, it provided satisfactory pain relief, motion improvement and overall patient gait

comfort for patients in a short-term period. They stated that TJR appeared to be a better solution

for less active older patients to whom it provides a loadable, painless, and moving joint. This

was a small study (n = 22 for the total joint replacement group) with short-term follow-up (18

months).

The ToeFit-Plus Prosthesis



The ToeFit-Plus is a modular implant system for the hemi-arthroplasty or total replacement of the

first MPJ. The non-cemented implant is fixed in the host bone by means of a self-tapping

threaded taper.

Duncan et al (2014) investigated the outcomes of first MP replacement for HR using the Smith &

Nephew ToeFit-Plus implant. These investigators assessed the outcomes of 69 first MPJ

replacements using the AOFAS score pre-operatively and annually post-operatively, with

retrospective radiologic review. All operations were performed by the same surgeon within 2

centers. A total of 69 arthroplasties were performed within the study period (57 patients). The

median AOFAS score at 1 year was 100 (interquartile range [IQR] 100 to 100), at 2 years was

100 (IQR 95 to 100), at 3 years was 100 (IQR 87.5 to 100), and at 4 years, it was 100 (IQR

91.25 to 100). Radiolucencies around the phalangeal component were seen in 23 cases;

however, this was symptomatic in only 2 patients, who required revision surgery. The authors

concluded that these early results showed that first MPJ replacement surgery with the ToeFit-

Plus™ prosthesis resulted in significant improvements in the AOFAS scores for most patients;

however, longer term follow-up is needed to monitor the clinical effect of radiolucency around the

phalangeal component.

Erkocak et al (2013) stated that although MTP arthrodesis has been advocated by many authors,

implant arthroplasty appears to be successful option in advanced HR. These investigators

evaluated the early results of the ToeFit-Plus prosthesis for the treatment of HR. Between

December 2007 and January 2011, a total of 26 toes of 24 patients with MTP arthritis of the

great toe were treated with ToeFit-Plus implant. The average follow-up time was 29.9 (range of

25 to 62) months. All patients were evaluated clinically and radiographically. Post-operative

satisfaction and function were scored according to the AOFAS score. Pain was assessed with

the use of a VAS. Mean pre-operative AOFAS score improved from 42.7 (range of 36 to 59) to

88.5 (range of 59 to 98) at the final follow-up (p < 0.01). Pre-operative average VAS pain scores

improved from 7.4 pre-operatively to 1.9 at the final follow-up (p < 0.01). The average MTP joint

ROM improved from 25.9 degrees pre-operatively to 53.8 degrees at the final follow-up. No

radiologic loosening was found, but radiolucency was observed in 2 patients with this implant.

No revision was required for any of the patients during the follow-up period. The authors

concluded that this total first MTP joint prosthesis yielded good functional outcome and high

patient satisfaction level with low early complication rate. Salvage arthrodesis remains an option

if future revisions are indicated. These preliminary findings need to be validated by well-

designed studies with larger sample size and longer follow-up.

In a single-surgeon, case-series study, Titchener et al (2015) evaluated the mid-term results of

first metatarsophalangeal joint replacement for hallux rigidus using ToeFit-Plus. These

investigators prospectively studied the outcomes of 86 toes in 73 patients using the AOFAS-HMI



score and radiological follow-up. The mean follow-up was 33 months (2 to 72); 10 patients have

been lost to follow-up; 8 patients sustained intra-operative fractures or impending fractures

requiring circlage wiring; 18 joints have either been revised or listed for revision giving a revision

rate of 24 %; this occurred at a mean of 33 months post-surgery. The authors concluded that 1st

MTPJ replacement is an option in hallux rigidus and patients who are not revised experienced

significant improvement in AOFAS scores in the medium term. These investigators had

previously published satisfactory results with this prosthesis. However the revision rate was

unacceptably high and they had discontinued its usecompletely.

Mermerkaya and Adli (2016) evaluated the short- to mid-term outcomes of metatarsal head-

resurfacing hemi-arthroplasty and total MTPJ arthroplasty (total joint replacement [TJR]) as

surgical treatments for advanced-stage HR. From 2012 to 2014, all data from patients who

underwent surgery for the treatment of grades 2 to 3 HR were retrospectively reviewed, and 45

patients were included in this study. Of these patients, 26 underwent metatarsal head-

resurfacing hemi-arthroplasty (Group I) and 19 underwent TJR (Group II). All patients were

clinically graded prior to surgery and at their final follow-up visits using the AOFAS-HMI scale,

VAS, and the 1st MTPJ ROM score. Metatarsal head resurfacing was performed on 26 patients;

2 patients underwent bilateral procedures, yielding a total of 28 cases in Group I; TJR was

performed on 19 patients in Group II. Of the 26 Group I patients, 12 (46.2 %) were men and 14

(53.8 %) were women, with a mean age of 56.3 ± 4.5 years (range of 47 to 63 years); the mean

follow-up duration was 29.9 ± 5.2 months. Of the 19 Group II patients, 8 (42.1 %) were men and

11 (57.9 %) were women, with a mean age of 57.1 ± 5.8 years (range of 45 to 66 years); the

mean follow-up duration was 27.1 ± 7.5 months. Significant improvements were evident in the

AOFAS scores, and the VAS scores decreased, in both groups. No significant difference was

evident between groups I and II. The authors concluded that after failure of conservative

treatment in patients with moderate-to-severe HR, both MTPJ hemi-arthroplasty and TJR were

associated with effective recovery of toe function and MTPJ ROM, as well as good short- to mid-

term functional outcomes.

This study was limited by its observational and retrospective design and relatively small sample

size (n = 45). Another drawback was that all procedures were performed by 2 surgeons, using a

standardized technique, in 2 centers. Furthermore, these investigators did not evaluate patient

satisfaction (e.g., by using the Medical Health Outcomes Short-Form 36-item survey

instrument). The authors stated that a prospective, multi-center randomized trial is needed.

Comparative studies of the long-term outcomes of various surgical techniques, with larger case

series of similar patients, are needed. If conservative treatment failed in patients with moderate-

to-severe HR, 1st-MTPJ hemi-arthroplasty and TJR effectively permit recovery of toe function

and 1st-MTPJ ROM, in addition to affording good short- to mid-term functional outcomes.



Gupta and Masud (2017) stated that HR is osteoarthritis (OA) affecting the MTPJ of the 1st toe.

Patients often complain of pain and stiffness with pain being aggravated by walking, particularly

during toe-off in the gait cycle. Osteoarthritis of the MTPJ is commonly treated with arthrodesis

or resection arthroplasty. Metallic replacement of this joint is used sometimes but is not widely

accepted. The use of silastic joints has problems with synovitis and implant failure. These

investigators used titanium implants, which can be screwed into the metatarsal and phalanx,

allowing good fixation without the use of bone cement. Release of the tight plantar capsule and

tissues is necessary to achieve better ROM and correct implant positioning. In this study, a total

of 55 cases of OA of the 1st MTPJ were treated surgically with Toefit-Plus joint replacement.

The implant consists of both metatarsal and phalangal components and a fixed-bearing

polyethylene insert. All patients had a release of tight soft tissues on the plantar side. Follow-up

occurred at 84 to 144 months after surgery (mean of 134 months), and the results showed

increasing numbers of implant failures and revisions (21 %) of Toefit-Plus implants; 47 patients

were available for review; 24 (51 %) out of 47 patients reported satisfactory results with Toefit-

Plus arthroplasty; 10 of these patients (21 %) had removal of implants and further surgical

procedures were needed due to implant failure; 11 (23 %) out of 47 patients still complained of

pain despite having joint replacement with the Toefit-Plus implant. There was a high rate of

complications with the Toefit-Plus implant resulting in revision surgery. Patients should have the

risks associated with arthroplasty clearly explained, including the risk of revision, and the option

of arthrodesis should be discussed when planning surgery. The authors conclude that further

trials and re-design of implants may help to improve results; they would not recommend the

Toefit-Plus implant due to poor results seen in 1/3 ofpatients.

Interpositional Arthroplasty of the First Metatarsophalangeal Joint

Aynardi and colleagues (2017) stated that for patients with HR seeking a motion-sparing

procedure, interposition arthroplasty is an alternative to fusion. In a retrospective, case-series

study, these researchers reported patient outcomes after interpositional arthroplasty for HR. All

patients undergoing interpositional arthroplasty at the authors’ institution from 2001 to 2014 were

identified and a retrospective chart review was performed. Follow-up was conducted through a

telephone survey to obtain survivorship, satisfaction, and functional scores. Survivorship of the

interpositional arthroplasty procedure was defined as no subsequent surgery on the hallux after

the index procedure. Patients were excluded for incomplete records; complications were

recorded. From 2001 to 2014, a total of 183 pa tients were identified. Of these, 14 were

excluded for incomplete data, leaving 169 patients. Of these, 133 had an average follow-up of

62.2 months (range of 24.3 months to 151.2 months). The overall failure rate was 3.8 %

(5/133). Patient-reported outcome was rated as excellent in 65.4 % (87/133) or good in 24.1 %

(32/133) of patients and fair or poor in 10.5 % (14/133) of patients. Of 133 patients, 101 (76 %)

were able to return to fashionable or regular foot-wear. The infection rate was 1.5 % (2/133).



Patient-reported cock-up deformity of the 1st MTPJ occurred in 4.5 % (6/133) of patients. In

addition, 17.3 % (23/133) of patients reported metatarsalgia of the 2nd or 3rd MTPJ at the time

of final follow-up, and there was no significant difference between interposition types (p =

0.441). The authors concluded that interpositional arthroplasty for HR was found to have

excellent or good results in most patients at a mean follow-up of 62.2 months. Level of Evidence

= IV.

Modular Implants

Dulgeroglu and Metineren (2017) noted that the treatment of advanced hallux rigidus remains

controversial. Only a few studies have analyzed the short- and mid-term results of MTP joint

arthroplasty to treat patients with advanced hallux rigidus. These researchers presented the

short-term follow-up results of patients who underwent MTP joint arthroplasty. They reviewed

the medical records of 15 consecutive patients (3 men and 12 women) who had had grade 3 or 4

hallux rigidus diagnosed according to the Coughlin and Shurnas classification. The age range at

surgery was 44 to 74 (mean of 61.6) years. The mean follow-up period was 21.7 (range of 18 to

28) months. The mean change in the overall AOFAS Hallux-First Ray scale score was from 26.9

± 2.3 pre-operatively to 78.7 ± 8.8 post-operatively (p < 0.005). The mean change in the overall

VAS score was from 8.3 ± 0.8 pre-operatively to 1.7 ± 0.7 post-operatively (p < 0.005). The

mean pre-operative 1st MTP joint ROM was 22.3° ± 7.7° (range of 15° to 45°), which had

increased to 77° (range of 65° to 90°) at the final follow-up visit. No patient required revision

surgery or removal. The authors concluded that these findings indicated that for patients with

advanced-stage hallux rigidus refractory to conservative treatment, total joint arthroplasty could

lead to good satisfaction and good functional results in the short-term.

Popelka and associates (2017) stated that the 1st MTP joint replacement ranks among the

treatment methods of patients with hallux rigidus. These researchers evaluated the short-term to

mid-term outcomes and presented their clinical experience with the Medin PH-flex implant. From

January 2011 to 2016, these investigators performed total replacement of the first MTP joint in 31

patients, in 4 cases bilaterally. In total, 35 implants were evaluated. The mean age of the patient

at the time of surgery was 57.7 years (39 to 72 years). The surgery was conducted in 29 women

and 2 men. The patients were evaluated using the AOFAS score, the radiographs were

assessed as to the potential occurrence of radiolucent lines, with major stress put on the

assessment of the mobility in MTP joint and its position. The pain was assessed based on the

VAS score. Prior to the joint replacement surgery, the mean AOFAS score in patients was 55.6

(35 to 65). Post-operatively, the mean AOFAS score was 80.8 (65 to 95). The pain suffered by

patients was evaluated with the use of the pain VAS score. The pre-operative mean VAS score

was 5 (2 to 8), whereas the post-operative score improved to mean VAS 2 (0 to 4). The ROM

was clinically assessed with a goniometer. The mean ROM of plantar flexion and dorsiflexion



was 16.00° (5 to 35°) and 28.60° (10 to 55°), respectively. The mean ROM was 36° (15 to 60°).

No intra-operative complications were observed. In all the patients, the surgical wound healed

per primam. In 2 female (5.7 %) of the whole group of patients who underwent surgery a deep

infection occurred, namely 10 and 21 months following the implantation. In both the female

patients their condition was managed by joint revision operation and by a simple removal of the

implant. The authors noted that joint replacement related matters were repeatedly discussed in

professional literature. There were many papers published in the literature on this topic. A whole

range of the first MTP joint implants of different shapes have been developed, with extremely

different clinical results. The authors concluded that an appropriately chosen type of the implant,

a fitting indication and a correctly applied implantation technique can lead to the desired good

outcome. The 1st MTP joint replacement should be indicated after careful consideration since

the management of a potential joint replacement failure can often be very technically challenging

and quite mutilating for the patient. The mid-term outcomes of the Medin 1st MTP implant

appeared to be promising. Moreover, they stated that it will be necessary to wait for long-term

outcomes in order to evaluate the final benefits of this type of implant in patients with hallux

rigidus.

Wassink and co-workers (2017) evaluated the results following total 1st MTP (FMTP) joint

replacement arthroplasty using a modular 3-component press fit prosthesis at 2- year follow-up.

All patient data were collected in a prospective way in 4 study centers. Both pre-operative and

post-operative evaluation consisted of an assessment using the AOFAS-HMI score, VAS for

pain, evaluation of the ROM and patient satisfaction scores. Post-operative X-rays were

reviewed for loosening and radiolucency up to 2 years. A total of 55 feet were available for

analysis at 24 months; 2 implants were removed during the study; 6 more feet had additional

surgery due to stiffness or mal-alignment. Post-operative AOFAS-HMI scores improved

significantly by 32.4 points at 2-year follow-up (p < 0.001). The VAS for pain improved

significantly from 6.8 (std 1,6) pre-operatively to 1.6 (std 1,9) post-operatively (p < 0.0001).

Mean dorsiflexion improved from 12.6 (std 10,1) degrees pre-operatively to 31.2 (std 16,8)

degrees post-operatively; 87 % of patients were moderately to well-satisfied with the end result;

18 prostheses showed radiolucency at 24 months. The authors concluded that implantation of a

Metis modular 3-component press fit prosthesis for the MTP joint in hallux rigidus showed

significant improvement in AOFAS-HMI scores and a decrease in pain. Moreover, they stated

that concerns remained with regard to early re-operation rate (14.5 %) and long-term survival of

the implant. They stated that future studies will have to address these aspects.

Stevens and colleagues (2017) stated that hallux rigidus is a common cause of foot pain in the

elderly and has a negative impact on quality of life (QOL). Several operative therapeutic options

are available for feet that are refractory to conservative treatment. Of these, TJR and

arthrodesis of the 1st MTP joint are the most commonly performed interventions. Nevertheless,



it is still unclear which intervention results in the best clinical outcome and the fewest

complications. These investigators performed a systematic review on the clinical outcome

following TJR and arthrodesis for hallux rigidus. PubMed/Medline, Embase, and the Cochrane

Library were systematically searched for studies assessing outcome with the AOFAS-HMI score,

Foot Function Index (FFI), VAS for pain, or SF-36 in patients who underwent an arthrodesis or

TJR for the treatment of symptomatic hallux rigidus. Secondary outcomes were complications

and revision rates. The screening of titles and abstracts, data collection, data extraction, and

study quality assessment were performed independently by 2 reviewers. Study quality was

determined with use of risk-of-bias tools. Results of included studies were presented in a

qualitative manner, and the results of high-quality studies were pooled. A total of 33 studies,

describing a total of 741 arthrodeses and 555 TJRs, were included in the qualitative analysis; 6

different prostheses were used for TJR, and various fixation techniques were used for

arthrodesis. The results of 6 arthrodesis studies and 7 TJR studies were pooled in the

quantitative analysis. Pooled results showed superiority of arthrodesis compared with TJR for

improving clinical outcome (by 43.8 versus 37.7 points on the AOFAS-HMI score) and reducing

pain (a decrease of 6.56 versus 4.65 points on the VAS pain score). Because of the rare

reporting of the FFI and SF-36, no comparison could be made for these outcomes. Fewer

intervention-related complications (23.1 % versus 26.3 %) and revisions (3.9 % versus 11 %)

were reported after arthrodesis as compared with TJR, with pain and nonunion and prosthetic

loosening being the most commonly reported complications after arthrodesis and TJR,

respectively. The authors concluded that the findings of the present systematic review of the

literature indicated that arthrodesis is superior for improving clinical outcome and reducing pain,

and is less often accompanied by intervention-related complications and revisions, compared

with TJR in patients with symptomatic hallux rigidus. Moreover, they stated that prospective

RCTs are needed to verify this conclusion. Level of Evidence =IV.

Cartiva Synthetic Cartilage Implant

Sciarretta (2013) stated that despite the various treatment options available, symptomatic

articular cartilage defects continue to represent a therapeutic challenge for knee surgeons.

These researchers retrospectively evaluated and presented long-term results, from 5 to 8 years,

of PVA-H hydrogel implants ("Cartiva") in the treatment of knee chondral focal defects.

Presented were the clinical and MRI evaluation of 18 patients with III and IV degree knee

chondral or osteochondral defects treated by PVA-H hydrogel implants. Defects were no larger

than 20 mm in diameter. Average age at time of surgery was 54 years. There were 11 male and

7 female patients. A total of 20 implants were implanted, 16 with 10-mm and 4 with 15-mm

Cartiva implants. One patient was treated bilaterally. The majority (80 %) of surgeries were

performed arthroscopically. Patients have been assessed by IKDC, SF36 scores and by MRI

imaging. All patients have shown improvement of knee function and knee scores, in many cases



over 50 points of IKDC, except 3. Of these, the 1st maintained a rather good quality of life for

over 5 years with approximately the same level of functionality she enjoys now, after implant

removal and knee replacement during 2008. The 2nd case was a 43-year old female with a

post-traumatic chondral defect in a valgus knee. The patient experienced post-op pain: the

implant was removed among another institution at 6 months post-op and was converted to

OATS. The 3rd case was a 49-year old male with a severe arthritic pre-op knee and may not

have been ideal candidate for Cartiva, but was too young for a total knee replacement (TKR) at

the time of operation and, despite a severe knee worsening during the last year that will need in

the short future a knee replacement, has, at over 6 years follow-up, an IKDC score of 33.33 from

a pre-op of 37.93. The authors concluded that 5- to 8-year follow-ups enabled them to conclude

that the use of PVA-H synthetic implants in knee chondral defects in middle aged patients can

guarantee critical knee function improvement and severe pain reduction. Even the patients, who

have needed a knee replacement, had done well for the first 4 to 5 years; meaning that this type

of treatment with the correct indications and future implant and instrumentation improvements,

already in course, may guarantee a several year-period of knee health and active life style. This

was a small study (n = 18) that examined the use of Cartiva for knee chondral or osteochondral

defects (not the big toe); and 5 to 8 years follow-up provided only medium-term, not long-term,

results.

Baumhauer and colleagues (2016) stated that although a variety of great toe implants have been

tried in an attempt to maintain toe motion, the majority have failed with loosening, mal-

alignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to

arthrodesis is more complicated and results in shortening of the ray or requires structural bone

graft to reestablish length. This prospective study compared the safety and effectiveness of this

small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-

stage hallux rigidus. In this prospective, randomized non-inferiority study, patients from 12

centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage

implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome

measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion

motion, secondary procedures, radiographic assessment, and safety parameters were

evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT)

methodology. The primary end-point for the study consisted of a single composite end-point

using the 3 primary study outcomes (pain, function, and safety). The individual subject's

outcome was considered a success if all of the following criteria were met: (i) improvement

(decrease) from baseline in VAS pain of greater than or equal to 30 % at 12 months; (ii)

maintenance of function from baseline in FAAM sports sub-score at 12 months; and (iii) absence

of major safety events at 2 years. The proportion of successes in each group was determined

and 1-sided 95 % confidence interval (CI) for the difference between treatment groups was

calculated. Non-inferiority of the implant to arthrodesis was considered statistically significant if



the 1-sided 95 % lower confidence interval was greater than the equivalence limit (less than 15

%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17

patients withdrew after randomization, and 22 were non-randomized training patients, leaving

152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were

similar for both groups. VAS pain scores decreased significantly in both the implant and

arthrodesis groups from baseline at 12 and 24 months. Similarly, the FAAM sports and activity of

daily living sub-scores improved significantly at 12 and 24 months in both groups. First MTP

active dorsiflexion motion improvement was 6.2 degrees (27.3 %) after implant placement and

was maintained at 24 months. Subsequent secondary surgeries occurred in 17 (11.2 %) implant

patients (17 procedures) and 6 (12.0 %) arthrodesis patients (7 procedures); 14 (9.2 %) implants

were removed and converted to arthrodesis, and 6 (12.0 %) arthrodesis patients (7 procedures

[14 %]) had isolated screws or plate and screw removal. There were no cases of implant

fragmentation, wear, or bone loss. When analyzing the ITT and mITT population for the primary

composite outcome of VAS pain, function (FAAM sports), and safety, there was statistical

equivalence between the implant and arthrodesis groups. The authors concluded that the

findings of this study showed equivalent pain relief and functional outcomes. The synthetic

implant was an excellent alternative to arthrodesis in patients who wished to maintain first MTP

motion. The percentage of secondary surgical procedures was similar between groups. Less

than 10 % of the implant group required revision to arthrodesis at 2 years. This study provided

only short-term results (12 to 24 months).

Baumhauer and associates (2017) conducted a prospective, randomized study to examine

outcomes of arthrodesis compared to synthetic cartilage implant in patients with hallux rigidus.

Patients underwent pre-operative clinical examination, radiographic assessment, hallux rigidus

grade assignment, and intra-operative assessment of cartilage loss; VAS score for pain was

obtained pre-operatively and at 24 months. Correlation was made between active peak

dorsiflexion, VAS pain, cartilage loss, and hallux rigidus grade. Fisher's exact test was used to

assess grade impact on clinical success (p < 0.05). In 202 patients, 59 (29 %), 110 (55 %), and

33 (16 %) were classified as Coughlin grades 2, 3, and 4, respectively. There was no correlation

between grade and active peak dorsiflexion (-0.069, p = 0.327) or VAS pain (-0.078, p = 0.271).

Rank correlations between grade and cartilage loss were significant, but correlations were

small. When stratified by grade, composite success rates between the 2 treatments were nearly

identical. The authors concluded that irrespective of the grade, positive outcomes were

demonstrated for both fusion and synthetic cartilage implant. Clinical symptoms and signs

should be used to guide treatment, rather than a grade consisting of radiographic, symptoms,

and ROM factors. This study provided only short-term follow-up (24 months).



Goldberg and co-workers (2017) examined data from a clinical trial of 1st metatarsophalangeal

joint (MTPJ1) implant hemiarthroplasty and arthrodesis to determine the association between

patient factors and clinical outcomes. Patients greater than or equal to 18 years with hallux

rigidus grade 2, 3, or 4 were treated with synthetic cartilage implant MTPJ1 hemiarthroplasty or

arthrodesis. Pain VAS, Foot and Ankle Ability Measure (FAAM) sports and activities of daily

living (ADL) scores, and SF-36 Physical Function (SF-36 PF) sub-score were obtained pre-

operatively, and at 2, 6, 12, 24, 52, and 104 weeks post-operatively. Final outcome data, great

toe active dorsiflexion motion, secondary procedures, radiographs, and safety parameters were

evaluated for 129 implant hemiarthroplasties and 47 arthrodeses. The composite primary end-

point criteria for clinical success included VAS pain reduction greater than or equal to 30 %,

maintenance/improvement in function, no radiographic complications, and no secondary surgical

intervention at 24 months. Predictor variables included hallux rigidus grade; gender; age; body

mass index (BMI); symptom duration; prior MTPJ1 surgery; pre-operative hallux valgus angle,

ROM, and pain. Two-sided Fisher exact test was used (p < 0.05). Success rates between

implant MTPJ1 hemiarthroplasty and arthrodesis were similar (p > 0.05) when stratified by hallux

rigidus grade, gender, age, BMI, symptom duration, prior MTPJ1 surgery status, and pre-

operative VAS pain, hallux valgus, and ROM. The authors concluded that synthetic cartilage

implant hemiarthroplasty was appropriate for patients with grade 2, 3, or 4 hallux rigidus. Its

results in those with associated mild hallux valgus (less than or equal to 20 degrees) or

substantial pre-operative stiffness were equivalent to MTPJ1 fusion, irrespective of gender, age,

BMI, hallux rigidus grade, pre-operative pain or symptomduration.

In a “Letter to the Editor” regarding the 2016 study by Baumhauer et al, Kane (2017) stated that

“These data are presented as level I evidence that a new implant device is “equivalent to the

gold standard” of joint arthrodesis for treatment of hallux rigidus. This statement has several

faults. The study was, in its design, not randomized. The authors admit that 22 of the 219

patients enrolled in the study protocol were chosen as “implant training patients” and were

therefore not randomized in their treatment. There is no way for the reader to know whether this

allocation was unbiased. It is easy to overlook such a small proportion of the total, but this

methodology nonetheless disqualifies the study from being a randomized trial. It is interesting

that the authors chose to enroll patients with grades 2 through 4 hallux rigidus. In their original

classification system, Coughlin and Shurnas recommend reserving arthrodesis for joints with

grades 3 and 4 disease. Their results illustrate that patients with grade 2 hallux rigidus have

satisfactory outcomes when simply treated with cheilectomy. The authors do not comment on

the etiology of their patients’ pathology; it is plausible that many grade 2 joints would have been

successfully treated with joint-sparing procedures, such as decompressional osteotomy of the

first metatarsophalangeal joint. Recent evidence also suggests that joint-sparing correction is a

viable treatment option even in truly advanced hallux rigidus. The enrollment of patients without

end-stage disease for a joint-destructive procedure -- who may excel with less drastic



intervention -- without first attempting more conservative procedures deviates from standard of

practice and may predispose those patients to otherwise avoidable arthrosis elsewhere in the

kinetic chain or permanent and unwarranted limitations in function. The authors repeatedly

highlight statistical differences in functional measures between the groups early in the

postoperative course (when the arthrodesis group was non-weightbearing) to support use of this

device, yet they seem to ignore data at later time points that illustrate the opposite result. In

addition, there is no discussion regarding the consistent finding at every postoperative time point

that patients receiving arthrodesis reported significantly less pain on the visual analog scale than

patients in the implant group. I commend the authors on collecting many outcome measures,

but it is important to discuss all findings -- especially when statistical significance is achieved.

Although the authors claim no conflict of interest in their publication of this study, it is concerning

that many of the authors received direct financial support during the study period from the

companies that produce this new device. Indeed, it seems that the selective focus on supporting

data and disregard for conflicting data is the underlying theme of this article. Imperfect study

design and a selective discussion mislead the reader”.

Daniels et al (2017) noted that hallux rigidus is the most common arthritic condition of the foot. A

randomized clinical trial of 1st metatarsophalangeal (MTP) joint hemiarthroplasty with a polyvinyl

alcohol (PVA) hydrogel implant (Cartiva) demonstrated pain relief and functional outcomes

equivalent to 1st MTP arthrodesis at 2 years post-operation, with no cases of implant

fragmentation, wear, or bone loss. In a prospective, case-series study, these researchers

determined mid-term (5-year) outcomes of 1st MTP hemiarthroplasty with the PVA hydrogel

implant. Patients who underwent first PVA hydrogel MTP hemiarthroplasty in the previously

reported trial were evaluated at 5 years post-operatively. Patients underwent physical

examination and radiographic evaluation and completed a pain visual analog scale (VAS), the

Short-Form-36 (SF-36), and the Foot and Ankle Ability Measure (FAAM) sports subscale and

activities of daily living (ADL) sub-scale. At the time of this study, 29 patients had reached 5

years' follow-up; 2 were lost to follow-up, leaving 27 patients with mean age 56.1 (range of 40.1

to 71.9) years. Mean follow-up was 5.4 (range of 4.9 to 6.4) years. Post-operative active MTP

natural joint dorsiflexion and peak MTP dorsiflexion were mean 18.2 (range of 10.0 to 30.0) and

29.7 (range of 10.0 to 45.0) degrees, respectively. Pain VAS, SF-36 PCS, FAAM ADL, and

FAAM Sports scores demonstrated clinically and statistically significant improvements.

Radiographically, no patient demonstrated changes in implant position, implant loosening or

subsidence, or implant wear; 1 implant was removed because of persistent pain and converted

to fusion 2 years post-surgery. The authors concluded that 5 years following 1st MTP

hemiarthroplasty with a PVA hydrogel implant, functional outcomes improved significantly, pain

was reduced significantly, and the implant demonstrated excellent survivorship. Level of

Evidence = IV. This relatively small (n = 27) study provided only mid-term (5 years) follow-up

data.



Chang et al (2018) noted that the Cartiva implant (Cartiva, Alpharetta, GA) is an exciting option

in dramatically diminishing patient symptoms in advanced stages of hallux rigidus as well as

allowing continued joint motion. The procedure does not burn many bridges in case a future

revision to an arthrodesis is needed. This advantage is in contradistinction to other current

implants whereby more bone resection is needed for implant placement.

Glazebrook et al (2019) stated that a prospective, randomized, non-inferiority clinical trial of

synthetic cartilage implant hemiarthroplasty for hallux rigidus demonstrated functional outcomes

and safety equivalent to 1rst MTP joint arthrodesis at 24 months. In a prospective, case-series

study, these researchers evaluated the safety and efficacy outcomes for synthetic cartilage

implant hemiarthroplasty at a minimum of 5 years. Of 135 eligible patients from the original trial,

112 (83.0 %) were enrolled (mean age of 58.2 ± 8.8 years; 87 women); VAS, FAAM-ADL, and

FAAM-Sports subscales were completed pre-operatively and 2 and 5 years post-operatively.

Great toe active dorsiflexion, weight-bearing radiographs, secondary procedures, and safety

parameters were also evaluated. At 24 months, 14/152 (9.2 %) patients had undergone implant

removal and conversion to arthrodesis. In years 2 to 5, 9/119 (7.6 %) patients underwent implant

removal and conversion to arthrodesis. At mean 5.8 ± 0.7 (range of 4.4 to 8.0) years' follow-up,

pain VAS, FAAM-ADL, and FAAM-Sports scores improved by 57.9 ± 18.6 points, 33.0 ± 17.6

points, and 47.9 ± 27.1 points, respectively, from baseline. Clinically significant changes in VAS

pain, FAAM-ADL, and FAAM-Sports were reported by 103/106 (97.2 %), 95/105 (90.5 %), and

97/104 (93.3 %) patients, respectively. Patient-reported outcomes at 24 months were

maintained at 5.8 years in patients who were not revised. Active MTP joint peak dorsiflexion was

maintained; 99 of 106 (93.4 %) patients would have the procedure again. The authors

concluded that clinical and safety outcomes for synthetic cartilage implant hemiarthroplasty

observed at 2 years were maintained at 5.8 years. The implant remains a viable therapeutic

option to decrease pain, improve function, and maintain motion for advanced hallux rigidus.

Level of Evidence = IV. This study provided only mid-term (5 years) follow-up data; and

appeared to be an longer follow-up evaluation of patients reported in the 2017 Goldberg study.

The authors stated that a limitation of this study was the lack of outcome data for the control

group of arthrodesis patients; thus, the outcomes of synthetic cartilage implant hemi-arthroplasty

could not be compared with those of 1st MTP joint arthrodesis at 5 years’ follow-up. Another

limitation was the patients who were lost to follow-up (12 % for the primary outcome measure of

survivorship), although analysis of the primary outcome measure demonstrated that missing data

did not affect primary analysis.



CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

Code Code Description

28291 Hallux rigidus correction with cheilectomy, debridement and capsular release of the

first metatarsophalangeal joint; with implant

28293 Correction, hallux valgus (bunion), with or without sesamoidectomy; resection of

joint with implant

26535 Arthroplasty, interphalangeal joint; each joint

26536 with prosthetic implant, each joint

L8641 Metatarsal joint implant [not covered for the METIS® prosthesis and the

ToeFit-Plus™ prosthesis]

L8642 Hallux implant [not covered for the METIS® prosthesis and the ToeFit-Plus™

prosthesis]

L8658 Interphalangeal joint spacer, silicone o r equal, each

M20.20 - M20.22 Hallux rigidus

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constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or

program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any

results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna

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updated and therefore is subject to change.

Copyright © 2001-2019 Aetna Inc.



Proprietary

AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical PolicyBulletin Number: 0708 Metatarsal Phalangeal Joint Replacement

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania revised 10/04/2019

http://www.aetnabetterhealth.com/pennsylvania

prior authorization review panel mco policy submission a ......cartiva synthetic cartilage implant,...

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