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| ID | Type | Description | Link |
|---|---|---|---|
| H-C-2008-065 |
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| Name | Class |
|---|---|
| Aalborg University Hospital | OTHER |
| Zealand University Hospital | OTHER |
| Odense University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteosynthesis | Experimental |
| |
| Non-surgical | Experimental |
| |
| Hemiarthroplasty | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical management | Procedure | Non-surgical management (physiotherapy and self-training) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Constant Disability Scale | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Shoulder Score, Short Form-36 | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stig Brorson, MD, PhD | Contact | sbrorson@hotmail.com | ||
| Asbjørn Hrobjartsson, MD, PhD | Contact | ah@cochrane.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev University Hospital, Department Orthopaedic Surgery | Recruiting | Herlev | Denmark | DK-2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727196 | Derived | Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D062785 | Hemiarthroplasty |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Osteosynthesis | Procedure | Osteosynthesis with angle-stable plate followed by physiotherapy and self-training |
|
| Hemiarthroplasty | Procedure | Primary modular hemiarthroplasty followed by physiotherapy and self-training |
|
| D019643 |
| Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |