Status:
COMPLETED
Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
Musculoskeletal Transplant Foundation
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques. One technique used is t...
Eligibility Criteria
Inclusion
- Evidence of a rotator cuff tear as determined by clinical examination and diagnostic imaging (MRI)
- Patient undergoes arthroscopic rotator cuff repair
- Age 18 or older
Exclusion
- Pre-operative exclusion criteria
- Patient has had a previous arthroscopic rotator cut repair
- A previous diagnosis of Rheumatoid Arthritis
- Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous surgery of the affected shoulder,
- Evidence of significant rotator cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
- Medical device that would exclude the patient from having a MRI, including a pacemaker, cardiac defibrillator, aneurysm clips, carotid artery clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, or ear implant.
- Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
- Inability to speak or read English
- Psychiatric illness that precludes informed consent.
- Pregnant patients.
- Age 17 or younger
- Unwillingness to be followed for 2 years.
- Bilateral Rotator cuff tear confirmed by clinical exam and MRI
- Patients enrolled in the study who demonstrate retear on clinical exam and MRI, then elect for a repeat surgery.
- Intra-operative exclusion criteria (Note: This information will be collected during the chart audit and patients will be excluded from the study at that time.)
- Irreparable cuff tears or tears extending into the subscapularis or teres minor
- Isolated teres minor or subscapularis tears.
- Inelastic and immobile tendon which cannot be advanced to articular margin
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT02256891
Start Date
July 1 2011
End Date
December 1 2015
Last Update
August 9 2017
Active Locations (1)
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1
TRIA Orthopaedic Center
Bloomington, Minnesota, United States, 55431