Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835562
|Contact: Stig Brorson, MD, PhDfirstname.lastname@example.org|
|Contact: Asbjørn Hrobjartsson, MD, PhDemail@example.com|
|Herlev University Hospital, Department Orthopaedic Surgery||Recruiting|
|Herlev, Denmark, DK-2730|
|Contact: Stig Brorson, MD, PhD firstname.lastname@example.org|
|Contact: Asbjørn Hrobjartsson, MD, PhD email@example.com|
|Principal Investigator: Stig Brorson, MD, PhD|