|- candidate number||8315|
|- NTR Number||NTR2461|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-aug-2010|
|- Secondary IDs||NL29934.042.09 METC UMCG|
|- Public Title||Hemiarthroplasty versus Osteosynthesis in humeral fractures (HOMERUS): A Multicenter Randomized trial.|
|- Scientific Title||Three- and four-part fracture of the proximal humerus in the elderly. Angle stable locking compression plate osteosynthesis versus hemiarthroplasty.|
|- hypothesis||Hemiarthroplasty will show quicker recovery of functional capacity of the affected upper limb in 2 years compared with open reduction and internal fixation with an angle stable locking compression plate in the treatment of dislocated three and four part fractures of the proximal humerus.|
|- Healt Condition(s) or Problem(s) studied||Plate fixation, Hemiarthroplasty, Proximal humeral fracture, Shoulder prothesis|
|- Inclusion criteria||1. 3- and 4- fragment fracture proximal humerus according to the Neer classification;|
2. >5 mm dislocation in one of the fracture planes;
3. >60 years.
|- Exclusion criteria||1. Fracture existing more than 14 days;|
2. ASA IV-V;
3. Multitrauma , ISS > 16;
4. Pathological fracture;
5. Previous surgery on injured shoulder;
6. Severely deranged function caused by a previous disease;
7. “Head Split”fracture proximal humerus;
8. Unwillingness or inability to follow instructions.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2010|
|- planned closingdate||31-aug-2012|
|- Target number of participants||134|
|- Interventions||1. Hemiarthroplasty;|
2. Angle stable locking compression plate osteosynthesis.
|- Primary outcome||Speed of recovery of functional capacity of the affected upper limb measured with the DASH.|
|- Secondary outcome||1. Pain (VAS);|
2. Patient satisfaction (VAS);
3. Shoulder function (Constant-Murley Score);
4. Quality of life (SF-36);
5. Radiographic evaluation;
|- Timepoints||Baseline, 3 months, 6 months, 9 months, 12 months, 24 months.|
|- Trial web firstname.lastname@example.org|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. R.L. Diercks|
|- CONTACT for SCIENTIFIC QUERIES||Drs. P.A. Verbeek|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department Orthopaedic Surgery|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen, Department of Orthopaedic Surgery-Traumatology|
|- Brief summary||Rationale:|
The optimal surgical management of three- and four-part proximal humeral fractures in elderly osteoporotic patients remains controversial. Mostly used techniques are hemiarthroplasty and angle stable locking compression osteosynthesis. In literature there is no evidence available showing advantage of angle stable locking compression plate osteosynthesis compared to hemiarthroplasty regarding speed of recovery of functional capacity, pain, patient satisfaction,functional outcome, quality of life, and complications.
The objective of this study is to conduct a randomized controlled trial to compare hemiarthroplasty with open reduction and internal fixation with an angle stable locking compression plate in the treatment of dislocated three- and four-part fractures of the proximal humerus in the elder population. Primary outcome parameter is speed of recovery of functional capacity of the effected upper limb. We hypothesize that hemiarthroplasty shows quicker recovery of functional capacity. Secondary outcome parameters are pain,patient satisfaction, functional outcome, quality of life, radiographic evaluation and complications.
A prospective, non-blinded, multicentric randomized controlled trial will be conducted to allocate patients to either hemiarthroplasty or open reduction and internal fixation with angle stable locking compression plate osteosynthesis to study speed of recovery of functional capacity and other secondary outcomes.
Patients to be included suffer from three- or four- part fracture of the proximal humerus according to the Neer classification with more than 5 mm dislocation in one of the fracture-planes and are aged above 60 years. Patients with a fracture existing more than 14 days, ASA IV-V, multitrauma (ISS>16), pathological fracture, previous surgery on the injured shoulder, severely deranged function caused by a previous disease, head-split proximal humerus fracture and unwillingness or inability to follow instruction are excluded.
One group will be treated by hemiarthroplasty and the other group will be treated by open reposition and internal fixation with a angle stable locking compression plate.
In this study the following outcome parameters will be assessed: speed of recovery of functional capacity of the effected upper limb (primary outcome), pain, patient satisfaction, functional outcome, quality of life, radiographic evaluation and complications (secondary outcomes).
|- Main changes (audit trail)|
|- RECORD||10-aug-2010 - 9-sep-2010|