Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
|ClinicalTrials.gov Identifier: NCT00835562|
Recruitment Status : Unknown
Verified June 2012 by Stig Brorson, Herlev Hospital.
Recruitment status was: Recruiting
First Posted : February 3, 2009
Last Update Posted : June 7, 2012
Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.
The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns.
The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.
|Condition or disease||Intervention/treatment||Phase|
|Proximal Humeral Fractures||Procedure: Non-surgical management Procedure: Osteosynthesis Procedure: Hemiarthroplasty||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Displaced Four-part Fractures of the Proximal Humerus in Elderly: a Multi-centre, Randomised Clinical Trial|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||March 2013|
Osteosynthesis with angle-stable plate followed by physiotherapy and self-training
Procedure: Non-surgical management
Non-surgical management (physiotherapy and self-training)
Primary modular hemiarthroplasty followed by physiotherapy and self-training
- Constant Disability Scale [ Time Frame: 3 years ]
- Oxford Shoulder Score, Short Form-36 [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835562
|Contact: Stig Brorson, MD, PhDemail@example.com|
|Contact: Asbjørn Hrobjartsson, MD, PhDfirstname.lastname@example.org|
|Herlev University Hospital, Department Orthopaedic Surgery||Recruiting|
|Herlev, Denmark, DK-2730|
|Contact: Stig Brorson, MD, PhD email@example.com|
|Contact: Asbjørn Hrobjartsson, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Stig Brorson, MD, PhD|