Status:
UNKNOWN
Demineralized Bone Matrix Rotator Cuff Study
Lead Sponsor:
Arthrex, Inc.
Conditions:
Rotator Cuff Injuries
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
Patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation.
Detailed Description
This is a prospective randomized study comparing the outcomes of patient undergoing rotator cuff repair with either an interpositional procedure administering demineralized bone matrix (DBM), or a con...
Eligibility Criteria
Inclusion
- The Subject is between the ages of 40 and 75 years.
- Subject is planning to undergo arthroscopic surgery for full thickness rotator cuff tears (RCT) of supraspinatus and infraspinatus muscles, who are candidates for demineralized bone matrix with BMC.
- Two tendon tear or tear size equal to or greater than 3cm
- Amenable to double-row repair
- Primary rotator cuff tears with or without superior labral tear and/or biceps tear)
Exclusion
- The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
- The Subject objects to use of allograft
- Irreparable Rotator Cuff Tear
- Complete full thickness subscapularis tears of \> than the superior 1/3 of the tendon (Lafosse grade 3 and above)
- \< 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
- Recurrent shoulder instability
- Intra-articular injections (steroids) within 1 month of surgery
- RCR revisions
- Subject MRI taken more than 12 months prior to surgery
- Pregnant or planning to become pregnant during the study period
- Workman's compensation case
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04686396
Start Date
September 1 2019
End Date
September 1 2024
Last Update
August 2 2021
Active Locations (1)
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1
Southern Oregon Orthopedics
Medford, Oregon, United States, 97504