The Nordic DeltaCon Trial - oslo-universitetssykehus.no · Rabi S et al. 2015 Operative vs...

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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


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?


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


310 000* Region Oslo

Our attending Norwegian hospitals


Oslo University Hospital Ullevål, Oslo

Haukeland University Hospital, Bergen

Lillehammer Hospital

Bærum Hospital

Østfold Hospital, Kalnes

Diakonhjemmet Hospital

4 5

3

6

1 2



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/



Some of the members


Important aspects

Proximal humeral fractures

Age

Osteoporosis

Compliance

Nerve injuries

Co-morbidity

Rotator cuff

Vascularinjuries


Treatment options


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



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


2 -part 3 -part 4 -part

OTA / AO fracture groups


T. Fjalestad 04/10Division of Orthopaedic Surgery / TF 04 /18



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)




T. Fjalestad 04/10

Exclusion criterias




https://esa.un.org/unpd/wpp/Maps/

Background


The Nordic countries and RCT’s

https://esa.un.org/unpd/wpp/Maps/

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


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.


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



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



The protocol


Godkjent av REK sør-øst D 17.04.2018 Ref. 2018 / 476

Publisert på ClinicalTrails 24.05.2018 ClinicalTrials.gov Identifier: NCT03531463

Patient approval


An important document: Acceptance or declining?


Non-included groupIncluded group

Data collection



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

https://berta.nitep.eu/#/

Data colletion



X

Control group: 2w: Remove sling


Primary outcome: Quick-DASH

The Nordic DeltaCon

Secondary outcome: OSS

The Nordic DeltaCon


STYRKEMÅLING

Noen utfordringer

Hvordan utføre ?

Hvilket måleinstrument ?

I hvilken posisjon med

armen?

Må være standardisert!

STYRKEMÅLING


Secondary outcome: Constant score

The DeltaCon Trial

Secondary outcomes: QoL & Health Economics

The DeltaCon Trial


Patient involvement


Patient involvement

Aim of the interviews:

Patient-centered medicine

5 patients at OUS accepted to

take part

goals

preferences

values


Patient form 1 of 3


Rehabilitation

The DeltaCon Trial


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


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


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



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


Is non-operative really treatment safe?

According to evidence: Yes

According to radiographs: No?

Time 0

Time 12

Control group

The DeltaCon Trial

Evidence




Evidence



Implemetation


Division of Orthopaedic Surgery / TF 01 /18Division of Orthopaedic Surgery / TF 04 /18

Is surgery safe?

EVIDENCE ?

INTERVENTION GROUP


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


Potential complications to operative treatment

INTERVENTION GROUP



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



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


The Nordic DeltaCon Trial

Tore Fjalestad MD. PhD.

Tone Mehlum Wagle PT.

Ortopedisk avdeling

OUS Ullevål


www.ous/ullevål/deltacon



Thank You


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