the nordic deltacon trial - oslo-universitetssykehus.no · rabi s et al. 2015 operative vs...
TRANSCRIPT
The Nordic DeltaCon Trial
Randomisert enkelt-blindet multisenter studie av komplekse
brudd i proksimale humerus
Reversert skulderproteseeller
ikke-operativ rehabilitering?
Tore Fjalestad prosjektansvarlig lege
Tone Wagle prosjektfysioterapeut
Ortopedisk avdeling
OUS Ullevål
Division of Orthopaedic Surgery / TF 09 /18
AGENDA
The Nordic DeltaCon RCT
Division of Orthopaedic Surgery / TF 09 /18
1) Hvem som er invitert til å delta
2) Kort om proksimale humerus brudd og dets egenart
3) Evidens pr. i dag og bakgrunn for studien
4) Gjennomføring
- Inklusjon- /eksklusjon
- Effektmål
- Logistikk
- Tidsramme
5) Spørsmål - diskusjon
Where?
The Nordic DeltaCon RCT
Oslo University Hospital Ullevål, Oslo
Haukeland University Hospital, Bergen
Lillehammer Hospital. Lillehammer
Bærum Hospital, Vestre Viken
Østfold Hospital, Kalnes, Fredrikstad
Diakonhjemmet Hospital, Oslo
Deltacon Hospitals includes
1.300 000 Norwegian inhabitants
Division of Orthopaedic Surgery / TF 05 /18
310 000* Region Oslo
Our attending Norwegian hospitals
The Nordic DeltaCon RCT
Oslo University Hospital Ullevål, Oslo
Haukeland University Hospital, Bergen
Lillehammer Hospital
Bærum Hospital
Østfold Hospital, Kalnes
Diakonhjemmet Hospital
4 5
3
6
1 2
Division of Orthopaedic Surgery / TF 01 /18
Division of Orthopaedic Surgery / TF 09 /18
Nordic DeltaCon Trial
A Nordic collaboration
Collaborating hospitals
Protocol authors:
Launonen A Tampere UH
Fjalestad T OUS
Wagle T OUS
Laitinen M Tampere UH
Lähdeoja T Helsinki UH
Ekholm C Sahlgrenska UH
Mattila VM Tampere UH
http://nitep.eu/en/team/
The Nordic DeltaCon RCT
Division of Orthopaedic Surgery / TF 04 /18
Some of the members
Division of Orthopaedic Surgery / TF 05 /18
Important aspects
Proximal humeral fractures
Age
Osteoporosis
Compliance
Nerve injuries
Co-morbidity
Rotator cuff
Vascularinjuries
Division of Orthopaedic Surgery / TF 05 /18
Treatment options
Proximal humeral fractures
Non-Operatve
Hemi-artroplasty
Reversedartroplasty
Head Replacem.?
ORIF Plate
ORIF Nail
Mini-invasive
Fx. classification
Age
Co-morbidity
Compliance
Rotator cuff
Osteoporosis
Axillary nerve
Operative
Non-Operative
Treatment algorithm
Proximal humeral fractures
Division of Orthopaedic Surgery / TF 05 /18
Om bruddklassifiseringen
AO / OTA generelt
DeltaCon spesielt
T. Fjalestad 04/10
AO / OTA 1996classification
Type A
Extra-articular
2 part
Type B
Extra-articular
3 – 4 – n -parts
Type C
Intra-articular
2018 Revision
Division of Orthopaedic Surgery / TF 04 /18
2 -part 3 -part 4 -part
OTA / AO fracture groups
Proximal humeral fractures
T. Fjalestad 04/10Division of Orthopaedic Surgery / TF 04 /18
OTA / AO fracture groups
Proximal humeral fractures
Universal modifiers [ … ]
1 = Non displaced 3 = Impacted 5 = Dislocation [ 5a, 5b…]
2 = Displaced 4 = Non impacted 7 = Diaphyseal extension
Qualifications ( … ) p = Both tuberosities
INCLUSION CRITERION
B1.1, B1.2 or C1.1, C3.1
Both includes subgroups: Displaced [2], Impacted [3] or Non impacted [4]
classified by radiographs and CT 3D
Valgus displacement (true frontal view) ≥ 45º or
Varus displacement (true frontal view) ≥ 30º and
Displacement head fragment - metaphysis ≥ 50 %
Displacement of
tuberosities =
imprecise measure
11-B2
(= 3 or 4 parts displaced, not dislocated, no caput split)
OTA / AO fracture groups
Proximal humeral fractures
Division of Orthopaedic Surgery / TF 09 /18
T. Fjalestad 04/10
Exclusion criterias
Proximal humeral fractures
Division of Orthopaedic Surgery / TF 09 /18
Division of Orthopaedic Surgery / TF 04 /18
https://esa.un.org/unpd/wpp/Maps/
Background
Proximal humeral fractures
The Nordic countries and RCT’s
Rabi S et al. 2015
Operative vs non-operative management of displaced proximal humeral
fractures in the elderly:
A systematic review and meta-analysis of randomized controlled trials.
Problems: 1. Few patients 2. No blinding
4 / 6 Scandinavian
Background
Proximal humeral fractures
CONCLUSION:
There is moderate quality evidence to suggest that there is
no difference in functional outcomes between the two
treatments.
Further high quality RCT are required to determine if
certain subgroup populations benefit from surgical
management.
Division of Orthopaedic Surgery / TF 09 /18
There is high or moderate quality evidence that, compared with non-surgical treatment,
surgery does not result in a better outcome at one and two years after injury.
Operative treatment is likely to result in a greater need for subsequent surgery
The evidence does not cover the treatment of
two-part tuberosity fractures
fractures in young people
high energy trauma
fracture dislocations
head splitting fractures
Insufficient evidence to inform the choices between different surgical interventions
2015
Important
No Reversed Prosthesis
Few C type fractures
Background
Proximal humeral fractures
Division of Orthopaedic Surgery / TF 09 /18
Orthopaedic Dept. / TF 04 /18
Tore Fjalestad MD, PhD, Consultant, Head of project group. Jan Erik Madsen, Professor PhD, Head of Trauma,
Orthopaedic Dept. Tom C. Ludvigsen MD, PhD, Head of Arthroscopy/Arthroplasty Upper Extremity. Petter Iversen MD,
Consultant. Tone Wagle PT, Project researcher.
The Delphi Trial
Proximal humeral fractures
Division of Orthopaedic Surgery / TF 04 /18
The protocol
The Nordic DeltaCon RCT
Godkjent av REK sør-øst D 17.04.2018 Ref. 2018 / 476
Publisert på ClinicalTrails 24.05.2018 ClinicalTrials.gov Identifier: NCT03531463
Patient approval
The Nordic DeltaCon RCT
An important document: Acceptance or declining?
Division of Orthopaedic Surgery / TF 04 /18
Non-included groupIncluded group
Data collection
The Nordic DeltaCon RCT
Division of Orthopaedic Surgery / TF 04 /18
Digital datainnsamling planlagt
Pas. svarer på nettbrett
Data sendes til Tampere U.H. database
https://berta.nitep.eu/#/
Personvernløsning –
Langvarig godkjennings prosess (april ?)
Alternativt inntil godkjent
«Gammel metode»: Papirskjema
Vesentlig mer arbeide
Muligheter for feil med ekstra ledd i datahåndtering
Prosjektet kjøper inn «godkjente» nettbrett med programvare
Alternativt: Linken gjøres tilgjengelig på vår nettside / lokale PC’er
Data colletion
The Nordic DeltaCon RCT
Division of Orthopaedic Surgery / TF 04 /18
X
Control group: 2w: Remove sling
STYRKEMÅLING
Noen utfordringer
Hvordan utføre ?
Hvilket måleinstrument ?
I hvilken posisjon med
armen?
Må være standardisert!
STYRKEMÅLING
Division of Orthopaedic Surgery / TF 09 /18
Secondary outcome: Constant score
The DeltaCon Trial
Secondary outcomes: QoL & Health Economics
The DeltaCon Trial
Division of Orthopaedic Surgery / TF 05 /18
Patient involvement
The Nordic DeltaCon RCT
Patient involvement
Aim of the interviews:
Patient-centered medicine
5 patients at OUS accepted to
take part
goals
preferences
values
Division of Orthopaedic Surgery / TF 09 /18
Patient form 1 of 3
Division of Orthopaedic Surgery / TF 05 /18
Immobilisation sling: Thorax support for 2 weeks
During this period:
Remove the sling once daily assisted by health
professionals for
Personal hygiene
Extending the elbow and anti-edema exercises
Control group
The DeltaCon Trial
Felles egentreningsprogram for alle Nordiske land.
Tilgjengelige på web-side i pdf. format for nedlasting / utskrift
Division of Orthopaedic Surgery / TF 09 /18
Treningsprogram 2018 v/ Tone Mehlum Wagle
Modell: Hege Thrygg. Foto: Trine Strøm
Both groups: Self exercises
The DeltaCon Trial
Inclusionstart 01.10.18
Interim analyzis
01.03.20 ?
Inclusioncompleted
01.09.21 ?
FU 2 yearcompleted
01.09.23?
Timeline
Proximal humeral fractures
150 pas. / 14 sentra = 11 pas./ senter
5 pas / år = 2,5 år + ?
Kvalitetskontroll
Rapporterte komplikasjoner monitoreres av uavhengig person
Interim-analyse ved midtveis inklusjonen.
Inclusion starts 75 included 150 included Short term results
Division of Orthopaedic Surgery / TF 09 /18
Division of Orthopaedic Surgery / TF 01 /18
Vanlige motforestillinger man møter:
«Denne må jo opereres…….»
«Du skal vel ikke operere dette bruddet med protese?»
Erfarte motforestillinger («type 5 ½ evidens»)
Min første RCT: kolleger ved eget sykehus
DelPhi: Kolleger ved andre sykehus
I planleggingen av DeltaCon
Fra pårørende
Utfordringer
The DeltaCon Trial
Pasientsamtalen sentral: Må vite at dette er en av to etablerte behandlinger
Division of Orthopaedic Surgery / TF 01 /18
Is non-operative really treatment safe?
According to evidence: Yes
According to radiographs: No?
Time 0
Time 12
Control group
The DeltaCon Trial
Division of Orthopaedic Surgery / TF 01 /18Division of Orthopaedic Surgery / TF 04 /18
Is surgery safe?
EVIDENCE ?
INTERVENTION GROUP
The Nordic DeltaCon RCT
62 patients older than 70 years were randomized to
RTSA (31 patients) and HA (31 patients). FU mean 28 months.
CONCLUSION
RSA resulted in better pain and function and lower revision rate.
Revision from HA to RSA does not appear to improve outcomes.
Sebastia-Forcada et al. 2014
Reverse shoulder arthroplasty versus hemiarthroplasty for acute
proximal humeral fractures.
A blinded, randomized, controlled, prospective study.
Orthopaedic Dept. / TF 10 /16
Evidence
The Nordic DeltaCon RCT
Potential complications to operative treatment
INTERVENTION GROUP
The Nordic DeltaCon RCT
Division of Orthopaedic Surgery / TF 04 /18
Complication When? Prevention
Infection < 12 months Periop. technique
Non-union or
Resorbtion of tuberosities 1 < 3 months Horse shoe graft
Loosening of the implant Infection / notching ? ?
Notching 2 5 -8 years Inferior overhang
Deltoid fatigue 8-10 years Offset - 42 mm ?
Periprosthetic fracture ? No
21
Horseshoe graft / Tubercle healing
The Nordic DeltaCon RCT
Division of Orthopaedic Surgery / TF 04 /18
Park 2016
Tubercle healing better with a bone block
U-shaped block from the humeral head as graft
3x Ticron 5 to cerclage the tubercels
Chun 2017 JSES
Functional outcome (14 healed / 24 resorbed):
Better external rotation, otherwise no diffrence
www.ous/ullevål/deltacon
Proximal humeral fractures
The Nordic DeltaCon Trial
Tore Fjalestad MD. PhD.
Tone Mehlum Wagle PT.
Ortopedisk avdeling
OUS Ullevål
Division of Orthopaedic Surgery / TF 09 /18
Thank You
Proximal humeral fractures
http://www.eso.org/public/norway/images/eso1606a/zoomable/
Division of Orthopaedic Surgery / TF 05 /18
Still searching for the answers…