The Nordic DeltaCon Trial

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The Nordic DeltaCon Trial

Randomisert enkelt-blindet multisenter studie av komplekse brudd I proksimale humerus

Reversert skulderprotese eller ikke-operativ rehabilitering?

Tore Fjalestad

prosjektansvarlig lege

Tone Wagle

prosjektfysioterapeut Ortopedisk avdeling

OUS Ullevål

Division of Orthopaedic Surgery / TF 09 /18

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AGENDA

1) Deltakende sykehus

2) Proksimale humerus brudd og dets egenart 3) Evidens pr. i dag og bakgrunn for studien 4) Gjennomføring

- Inklusjon- /eksklusjon - Effektmål

- Logistikk

- Tidsramme

(3)

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

1.3 million Norwegian inhabitants

Division of Orthopaedic Surgery / TF 05 /18 310 000* Region Oslo

(4)

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

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http://nitep.eu/en/team/

The Nordic DeltaCon RCT

Some of the members

(6)

Important aspects

Age

Osteoporosis

Compliance

Nerve injuries Co-morbidity

Rotator cuff Vascular

injuries

(7)

Treatment options

Proximal humeral fractures

Non-Operatve

Hemi- artroplasty

Reversed artroplasty

Head Replacem.?

ORIF Plate ORIF Nail

Mini-invasive

(8)

Fx. classification

Age

Co-morbidity Compliance

Rotator cuff Osteoporosis

Axillary nerve

Operative

Non-Operative Treatment algorithm

Om bruddklassifiseringen

 AO / OTA generelt

 DeltaCon spesielt

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T. Fjalestad 04/10

AO / OTA 1996

classification

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

Proximal humeral fractures

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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 and/or

 Varus displacement (true frontal view) ≥ 30º and/or

 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

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Orthopaedic Dept., Division of Surgery / TF 01/19

Scapula Y-projeksjon og Inklusjon

The Nordic DeltaCon RCT

Scalpula Y projeksjon (sidebilde) er ikke omtalt i inklusjonskriteriene. Imidlertid gjelder følgende:

Hvis denne vinkelen er >45 grader i et rett sidebilde, er det patologisk og vil også tilfredsstille inklusjonskriteriet i forhold til dislokasjon. Nedenfor et eksempel der dislokasjonen er mindre:

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T. Fjalestad 04/10

Exclusion criterias

• Glenoid pathology

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Division of Orthopaedic Surgery / TF 04 /18 https://esa.un.org/unpd/wpp/Maps/

Background

Proximal humeral fractures

The Nordic countries and RCT’s

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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.

Furtherhigh quality RCT are required to determine if certain subgroup populations benefit from surgical management.

(15)

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

(16)

The protocol

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

Publisert på ClinicalTrails 24.05.2018 ClinicalTrials.gov Identifier: NCT03531463

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Patient approval

The Nordic DeltaCon RCT

An important document: Acceptance or declining?

Non-included group

Included group

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Follow-up and outcomes: Adjustments

*PPI: Bare noen utvalgte pasienter ved Tampere, Århus og Ullevål

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Primary outcome: Quick-DASH

The Nordic DeltaCon

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Secondary outcome: OSS

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STYRKEMÅLING

Noen utfordringer:

Hvordan utføre

Hvilket måleinstrument I hvilken posisjon med armen

Må være standardisert

STYRKEMÅLING

Secondary outcome: Constant score

The DeltaCon Trial

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STRENGTH measurement in DeltaCon

 Type of device

 <60 degrees in the scapular plane

 The strap around the upper arm

 Standing or sitting position

Orthopaedic Dept., Division of Physiotherapy / TW 01/19

Constant score – STRENGTH

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Secondary outcomes: QoL & Health Economics

The DeltaCon Trial

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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

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Questions to ask

 What does it mean?

 Which recommendations has been given from Norwegian Health authorities?

 How can Deltacon implement this?

 Patients from Oslo, Tampere, Århus

Patient and Public Involvement Nordic DeltaCon Trial

The principle

«A person with an illness has a lot of knowledge that the healthy

does not know about»

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Rehabilitation

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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

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 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

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Inclusion start 01.10.18

Interim analyzis 01.03.20 ?

Inclusion completed

01.09.21 ?

FU 2 year completed

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

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Is non-operative really treatment safe?

According to evidence: Yes According to radiographs: No?

Time 0

Time 12

Control group

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Evidence

Proximal humeral fractures

(32)

Evidence

(33)

Implemetation

Proximal humeral fractures

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Potential complications to operative treatment

INTERVENTION GROUP

Complication When? Prevention

Infection < 12 months Periop. technique

Non-union or

Resorbtion of tuberosities < 3 months Horse shoe graft ¹

Loosening of the implant Infection / notching ? ?

Notching² 5 -8 years Inferior overhang

Deltoid fatigue 8-10 years Offset - 42 mm ?

Periprosthetic fracture ? No

1 2

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DeltaCon start-up in Norway

The Nordic DeltaCon trial

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DeltaCon start-up in Norway

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www.ous/ullevål/deltacon

Nordic DeltaCon Trial

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Thank You

http://www.eso.org/public/norway/images/eso1606a/zoomable/