The DELPHI- trial

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Fracture of the proximal humerus

A randomized study of two surgical treatments:

Reverse Total Shoulder Artroplasty versus

angular stable device Philos

Othopaedic Department Trauma

Oslo University Hospital

Tore Fjalestad MD PhD

T. Fjalestad 04/10

Orthopaedic Dept. 2/ 2013

The DELPHI- trial

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Global perspective ….

Fractures of the Proximal Humerus

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EPIDEMIOLOGY

Proximal Humeral Fractures

Orthopaedic Dept. / TF 05.12

 10% of all fractures

 30% of fractures in patients > Age 60

Population age > 60 during 1950 – 2050 ►

UN Population Division 2009

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27204

13219

11625

6299

1809

0 5000 10000 15000 20000 25000 30000

Hip fx Tibial fx ACL Rotator cuff P. Hum. fx

Number of publications May 2011

PubMed 2011

Fractures of the Proximal Humerus

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There is an urgent need to define more clearly the role and type of surgical intervention in the management of proximal humeral fracture.

Cochrane Recommendations

Any trials must take account of the important issues of method of

randomisation, blinding and duration of follow up. Such trials should use

 standard and validated outcome measures

 patient assessed functional outcomes

 resource implications

COCHRANE CONCLUSIONS

Fractures of the Proximal Humerus

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TYPES OF STUDIES

 Conservative vs. conservative

 Conservative vs. surgery

 Surgery vs. surgery

COCHRANE Last updated 2010 Fracture of the Proximal Humerus

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Is surgical treatment better?

Fracture of the Proximal Humerus

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REPORTING SCORE

Fracture of the Proximal Humerus

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www.clinicaltrials.gov

Fracture of the Proximal Humerus

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Fracture types

Fractures of the Proximal Humerus

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T. Fjalestad 04/10

Type A

Extra articular 2 part

Type B

Extra articular 3 or more parts

Type C

Intra articular

AO / OTA classification 1990 / 2007 Fractures of the Proximal Humerus

20 %

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Control Group

Fractures of the proximal humerus

60 patients

Open reduction and Philos +

tread cerclages to secure the tubercules

Patient nr. 2

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Philos angular stable implant Hemiproshesis Reverse Total Shoulder Artroplasty

SURGICAL OPTIONS

Fracture of the Proximal Humerus

Do Reverse Prothesis give a better functional outcome than ORIF ?

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T. Fjalestad 04/10

Ortopedisk avdeling. 1/ 2013

Pro et contra RTSA

Fracture of the Proximal Humerus

Proshesis Hemiprosthesis RTSA

Depends on Rotator cuff Deltoid muscle Healing of tubercules Critical Optimal results

Problem Not proven better

than Philos

Deltoid ”fatigue”

Scapular notching Revisjon / CS <30 Expected at 9-10 yrs Funksjon 40-50% poor More predictable

Evidence Level 1- 4 Level 3-4

The elderly patient with an acute PHF

 In total 20.000 RTSA during 20 years

 Indictations: Cuff artropathy, Revision of anatomical prosthesis

 ”Better outcome than hemiarthroplasty”

 Age limit 70 years? But PHF different from Cuff artropathy

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Level III evidence RTSA

Fractures of the proximal humerus

TFj 2012 TFj 2012

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Results and Complications of Reverse TSA Iannotti JP, Madden M, Cleveland Clinic ASES may 2012

OUS TF 2012

Survival RTSA

Fractures of the proximal humerus

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OUTCOMES

Fractures of the proximal humerus

Primary outcome

Constant score ”Blinded” physiotherapists

Problems Sensitivity, Validity, … Secondary outcomes

Oxford Shoulder score Shoulder specific self assessment

15D score Quality of Life - generic

→ Caclulation of QALY’s Economic Evaluation

Radiographic Evaluation

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The revised CONSORT statement. Altman et al 2010

Fractures of the Proximal Humerus

60 + 60 Calculated time 2.5 years

6 hosiptals Power 80%

Constant 10 points MIC

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http://www.oslo-universitetssykehus.no Fractures of the Proximal Humerus

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The web side DELPHI

Fractures of the Proximal Humerus

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The web side DELPHI

Fractures of the Proximal Humerus

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www. AO TRAUMALINE

Fractures of the proximal humerus

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Online randomization by NTNU webCRF Fractures of the proximal humerus

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The right direction …..?

Fractures of the proximal humerus

TF 2012

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A possibly answer within 7 years Fractures of the proximal humerus

TF 2012