Status:
UNKNOWN
Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery?
Lead Sponsor:
The University of Western Australia
Collaborating Sponsors:
Arthrex, Inc.
Conditions:
Supraspinatus Tear
Eligibility:
All Genders
50-75 years
Phase:
PHASE3
Brief Summary
The aim of this study is to establish if the application of autologous conditioned plasma (ACP), also described as platelet rich plasma (PRP), to the site of supraspinatus tendon repair beginning with...
Eligibility Criteria
Inclusion
- Aged 50-75 years;
- In a non-dependent relationship;
- Full-thickness supraspinatus tendon tear (deemed repairable);
- Pre-operative platelet count greater than 150 000.
Exclusion
- Previous rotator cuff repair surgery;
- Active/distal infection;
- Metabolic bone or blood disorders;
- Pre-existing conditions associated with upper extremity pain;
- Rotator cuff tears secondary to fracture;
- Prior ACP/PRP injections;
- Non-surgical rotator cuff treatment in the past month, including corticosteroids and anti-inflammatory treatment.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01414764
Start Date
May 1 2011
End Date
February 1 2015
Last Update
December 9 2014
Active Locations (1)
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1
Fremantle Hospital Radiology Department
Fremantle, Western Australia, Australia, 6160