Status:
COMPLETED
Impact of Autologous Platelet Rich Plasma on Healing of Rotator Cuff Repairs
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Mount Sinai Hospital, Canada
Conditions:
Rotator Cuff Pathology
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Partial-thickness and full-thickness rotator cuff tears are common soft-tissue conditions that often require surgical treatment. Initial efforts to improve tendon healing centered on improving the str...
Detailed Description
Surgical procedures: Arthroscopic inspection of the shoulder will be performed to assess intra-articular structures and to evaluate the rotator cuff and other sub-acromial structures. Arthroscopic Ro...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age \>18 years
- Diagnosis of partial or full-thickness rotator cuff tear of less or equal to 3 cm. confirmed by MRI or US within a period of 6 months prior to booking surgery.
- The final inclusion will be based on arthroscopic assessment of the tear size and lack of significant concurrent pathology.
- Exclusion Criteria
- Unable to speak or read English
- Non-repairable tear
- Acute tears (\<6 month)
- Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory arthropathy, frozen shoulder
- Concurrent pathology of Superior Labral Anterior and Posterior (SLAP) lesions, Bankart lesions, or advanced osteoarthritis of the glenohumeral joint
- Previous surgery of the affected shoulder
- Bone marrow pathology
- Abnormal platelet count
- Serum hemoglobin concentration \<11 g/dL or hematocrit \<34%
- Use of systemic cortisone
- Current use of anticoagulants (i.e. Aspirin)
- Use of an investigational drug and/or blood donation within the previous 3 months prior to surgery
- Substance or alcohol abuse
- Heavy smoking \[a daily cigarettes consumption of more than 20 pieces, based on definition of the World Health Organization (WHO)\]
- Psychiatric illness that precludes informed consent
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01000935
Start Date
March 1 2011
End Date
May 1 2015
Last Update
March 19 2020
Active Locations (2)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4Y1H1
2
Mount Sinai Hospital
Toronto, Ontario, Canada