Evaluation of Treatment of Fractures of the Humerus With a Plate.

Study Overview
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Brief Summary
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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).

Detailed Description
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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): Pain Activities of Daily Living (ADL) Range of Motion (ROM) Muscle strength We shall measure the following radiologic parameters: Healing (migration) of tuberculum majus and minus measured with use of MB-RSA Plate migration with use of MB-RSA Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA) Correlation between bone density and prosthesis migration (and tuberculum migration)

Official Title
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Evaluation of the Winsta PH Osteosynthesis Device in the Treatment of Three- and Four-Part Fractures of the Proximal Humerus A Prospective Migration and Bone Density Study

Conditions
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Fracture

Intervention / Treatment
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* Procedure: Winsta PH osteosynthesis device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with three-part and four-part proximal humeral fractures Aged 50 years or older and fit Informed, written consent A functioning shoulder preoperatively - Exclusion Criteria: Patients found unsuitable preoperatively for a shoulder Philos Plate Patients aged 85 or older Patients with rheumatoid arthritis Patients who previously had undergone shoulder plastic or other major shoulder surgery Patients unable to avoid NSAID after surgery Patients requiring regular systemic steroid treatment Female patients taking hormone substitution Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings) Patients with metabolic bone disease -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Winsta PH osteosynthesis device (Fischer Medical)for treatment of humeral fracture | Procedure: Winsta PH osteosynthesis device<br>* The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.<br>* Other names: Winsta PH osteosynthesis device (Fischer Medical);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing (migration) of tuberculum majus and minus measured with use of MB-RSA |  | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between bone density and prosthesis migration (and tuberculum migration) |  | five years | 
| Range of Motion (ROM) |  | five years | 
| Muscle strength |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fracture, shoulder, bone density, healing