Status:
COMPLETED
The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery
Lead Sponsor:
St. Antonius Hospital
Conditions:
Rotator Cuff Rupture
Subacromial Impingement
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
Subacromial surgery of the shoulder is performed often. It concerns space creating interventions (open and arthroscopic subacromial decompression) and rotator cuff surgery (open and arthroscopic). In ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01510639
Start Date
July 1 2010
End Date
April 1 2014
Last Update
May 1 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
st. Antoniusziekenhuis
Nieuwegein, Netherlands, 3430 EM