Status:
COMPLETED
Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears
Lead Sponsor:
BioMimetic Therapeutics
Conditions:
Full Thickness Rotator Cuff Tear
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be...
Eligibility Criteria
Inclusion
- The subject has a repairable rotator cuff tear with an estimated full thickness size of ≥ 2 cm to \< 5 cm confirmed with diagnostic MRI in AP or ML dimension
- The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits
- The subject is at least twenty one (21) years of age and considered to be skeletally mature.
Exclusion
- The subject has undergone previous rotator cuff repair surgery to the affected shoulder
- The subject has a partial thickness rotator cuff tear
- The subject requires a concomitant subscapularis repair
- The subject requires a concomitant labral repair
- The subject has an irreparable rotator cuff tear
- The subject has an allergy to yeast-derived products or a known bovine collagen allergy
- The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the shoulder
- The subject has tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed Augment Rotator Cuff implantation site
- The subject's condition represents a worker's compensation case
- The subject is currently involved in a health-related litigation procedure
- The subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period
Key Trial Info
Start Date :
November 24 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01256242
Start Date
November 24 2010
End Date
November 16 2012
Last Update
February 19 2019
Active Locations (4)
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1
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada, N6A 3K7
2
Hand and Upper Limb Clinic - St. Joseph's Health Care London
London, Ontario, Canada, N6A 4L6
3
Ottawa Hospital
Ottawa, Ontario, Canada
4
St. Michaels Hospital
Toronto, Ontario, Canada