Status:
UNKNOWN
Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study
Lead Sponsor:
Applied Biologics, LLC
Collaborating Sponsors:
Fondren Orthopedic Group L.L.P.
Texas Orthopedic Hospital
Conditions:
Rotator Cuff Tear
Fatty Atrophy
Eligibility:
All Genders
Phase:
NA
Brief Summary
Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction. A secondary injection will be administered at the time of re...
Detailed Description
Patients will be given a written explanation of the study and screened for inclusion and exclusion criteria. Included patients will have a repairable, full thickness rotator cuff tear limited to the s...
Eligibility Criteria
Inclusion
- Included patients will have a repairable, full thickness rotator cuff tear limited to the supraspinatus and infraspinatus, confirmed by MRI. Patients with concomitant biceps tenotomy, tenodesis, arthroscopic subacromial decompression, and distal clavicle excision will be included.
Exclusion
- Patients with prior operations on the shoulder, partial thickness tears, subscapularis tears or labral tears requiring repair, irreparable supraspinatus tears, staged bilateral rotator cuff repairs, or concomitant suprascapular nerve decompression will be excluded. We will also exclude patients with co-morbid conditions requiring the use of corticosteroids. Patients who cannot have an MRI for medical reasons will also be excluded.
Key Trial Info
Start Date :
March 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2019
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03379324
Start Date
March 24 2017
End Date
September 30 2019
Last Update
December 20 2017
Active Locations (1)
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1
Texas Orthopedic Hospital
Houston, Texas, United States, 77030