Subacromial Impingement Clinical Trial
— PRPOfficial title:
Results of Subacromial Surgery; The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery
Verified date | April 2014 |
Source | St. Antonius Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medical Ethics Review Committee (METC) |
Study type | Interventional |
The purpose of this study is to test the hypothesis that the application of PRP leads to faster wound healing, less wound healing disorders, less pain and faster functional recovery after subacromial surgery.
Status | Completed |
Enrollment | 73 |
Est. completion date | April 2014 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age >18 years old - Given informed consent - Clinical indication for Arthroscopic Sub-acromial decompression, i.e.: Painful arc, pain at abduction, positive Hawkinstest Insufficient clinical improvement after (at least) 6 months of conservative treatment or Clinical indication for a arthroscopic cuff repair of a MRI-proven treatable rotator cuff tear. Exclusion Criteria: - Coagulopathy - Thrombocytopenia - Use of corticosteroids - Diabetics Mellitus - Omarthritis - AC-arthrosis - Cuff arthropathy - Neurological deficit at the ipsi-lateral extremity - (Wish for) Pregnancy - VAS <2 or VAS >9 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | st. Antoniusziekenhuis | Nieuwegein |
Lead Sponsor | Collaborator |
---|---|
St. Antonius Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in VAS pain | Change in painscore measured on a VAS scale | 2 years | No |
Secondary | Functional recovery | Several questionnaires (RAND-36, SST, and Constant score) and functional tests are measured (Range of motion) | 2 years | No |
Secondary | The amount of patients that had adequate wound healing | At different follow-up moments would healing is evaluated (6 weeks - 12 weeks - 1 year - 2 years) | 2 years | No |
Secondary | The amount of patient who were able to resume their work | At different follow-up moments it is evaluated if patients was able to resume work (6 weeks - 12 weeks - 1 year - 2 years) | 2 years | No |
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