The DELPHI- trial · There is an urgent need to define more clearly the role and type of surgical...
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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 Orthopaedic Dept. 2/ 2013 The DELPHI- trial
Transcript of The DELPHI- trial · There is an urgent need to define more clearly the role and type of surgical...
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
Global perspective ….
Fractures of the Proximal Humerus
Orthopaedic Dept. 2/ 2013
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
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
Orthopaedic Dept. 2/ 2013
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
Orthopaedic Dept. 2/ 2013
TYPES OF STUDIES
Conservative vs. conservative
Conservative vs. surgery
Surgery vs. surgery
COCHRANE Last updated 2010
Fracture of the Proximal Humerus
Orthopaedic Dept. 2/ 2013
Is surgical treatment better?
Fracture of the Proximal Humerus
Orthopaedic Dept. 2/ 2013
REPORTING SCORE
Fracture of the Proximal Humerus
Orthopaedic Dept. 2/ 2013
www.clinicaltrials.gov
Fracture of the Proximal Humerus
Orthopaedic Dept. 2/ 2013
Fracture types
Fractures of the Proximal Humerus
Orthopaedic Dept. 2/ 2013
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 %
Orthopaedic Dept. 2/ 2013
Orthopaedic Dept. 2/ 2013
Control Group
Fractures of the proximal humerus
60 patients
Open reduction and Philos +
tread cerclages to secure the tubercules
Patient nr. 2
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 ?
Orthopaedic Dept. 2/ 2013
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
Orthopaedic Dept. 2/ 2013
Level III evidence RTSA
Fractures of the proximal humerus
TFj 2012 TFj 2012
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
Orthopaedic Dept. 2/ 2013
Orthopaedic Dept. 2/ 2013
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
The revised CONSORT statement. Altman et al 2010
Fractures of the Proximal Humerus
Orthopaedic Dept. 2/ 2013
60 + 60
Calculated time 2.5 years
6 hosiptals
Power 80%
Constant 10 points MIC
http://www.oslo-universitetssykehus.no
Fractures of the Proximal Humerus
Orthopaedic Dept. 2/ 2013
The web side DELPHI
Fractures of the Proximal Humerus
Ortopedisk avdeling. 1/ 2013
The web side DELPHI
Fractures of the Proximal Humerus
Ortopedisk avdeling. 1/ 2013
Orthopaedic Dept. 2/ 2013
www. AO TRAUMALINE
Fractures of the proximal humerus
Online randomization by NTNU webCRF
Fractures of the proximal humerus
Ortopedisk avdeling. 1/ 2013
Orthopaedic Dept. 2/ 2013
The right direction …..?
Fractures of the proximal humerus
TF 2012
A possibly answer within 7 years
Fractures of the proximal humerus
TF 2012
Orthopaedic Dept. 2/ 2013
