Status:
COMPLETED
Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Arthrex, Inc.
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Rotator cuff tears are a common injury that lead to pain and loss of function for those who suffer from it. Treatment includes the use of arthroscopic surgery to return function to the patient and red...
Eligibility Criteria
Inclusion
- Men or women who are between 18 and 70 years of age.
- Primary, traumatic or degenerative rotator cuff tears measuring 3 cm or less.
- Rotator cuff tears requiring arthroscopic repair within 18 months of initial diagnosis.
- Provision of informed consent.
Exclusion
- Rotator cuff tears secondary to a fracture.
- Patients with an associated dislocation at the time of randomization.
- Rotator cuff tears that underwent prior surgical repair or revision arthroscopy.
- Non-surgical rotator cuff associated treatment in the 1 month prior to randomization including corticosteroid injection and anti-inflammatory treatment.
- Prior platelet rich plasma injection.
- Pre-existing conditions associated with upper extremity pain, including arthritis, ongoing infection, carpal tunnel syndrome, cervical neuropathy or other nerve pathology, local malignancy, and systemic disorders (e.g., uncontrolled diabetes, hypothyroidism).
- Patients with gross shoulder instability.
- Patients with an active infection.
- Patients who are pregnant or plan to become pregnant in the next 12 months.
- Patients with a pre-operative platelet count less than 125,000 and a pre-operative hemoglobin of 7.5g/dl or less.
- Likely problems with follow-up (i.e. patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support).
- Patients who do not read and speak English.
- Patients participating in another ongoing trial that would interfere with the assessment of the primary or secondary outcomes.
- Any other reason (in the judgment of the surgeon).
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01170312
Start Date
September 1 2010
End Date
August 1 2012
Last Update
November 1 2012
Active Locations (3)
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1
McMaster University
Hamilton, Ontario, Canada, L8L8E7
2
Hamilton General Hospital
Hamilton, Ontario, Canada
3
McMaster Hospital
Hamilton, Ontario, Canada