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The purpose of this study is to study with the use of clinical and radiological parameters the treatment of three-part and four-part fractures with the Winsta PH osteosynthesis device (Fischer Medical).
We shall measure the following clinical parameters with the help of the Constant Shoulder Score (CSS) and Western Ontario Osteoarthritis of the Shoulder Index (WOOS):
We shall measure the following radiologic parameters:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Winsta PH osteosynthesis device (Fischer Medical)for treatment of humeral fracture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Winsta PH osteosynthesis device | Procedure | The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing (migration) of tuberculum majus and minus measured with use of Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA) | Migration of the tubercles measured with Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA) | five years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between bone density and prosthesis migration (and tuberculum migration) | five years | |
| Range of Motion (ROM) | five years | |
| Muscle strength |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be included at 2 orthopaedic departments at 2 hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Kjeld Soballe, Professor | Orthopaedic Department, Aarhus University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Department K, Silkeborg Hospital | Silkeborg | 8600 | 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 |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| five years |
| Activities of Daily Living (ADL) | five years |
| Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA) | five years |