Status:
ACTIVE_NOT_RECRUITING
Rotator Cuff Failure With Continuity
Lead Sponsor:
The Cleveland Clinic
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18-75 years
Brief Summary
This proposal's objective is to challenge and expand the current definition of rotator cuff healing by investigating tendon retraction - broadly defined as medial translation of the repaired tendon aw...
Detailed Description
Currently, rotator cuff healing is defined as "intact", "attenuated", or "failed" based on the observation (or not) of a recurrent defect (i.e., a "gap") in the tendon using MRI or ultrasound imaging....
Eligibility Criteria
Inclusion
- Males or females, ages 18-75 having an acute or chronic 1-5 cm wide (A-P) full thickness tear of only the supraspinatus and/or infraspinatus tendons; partial thickness tears of subscapularis or teres minor not requiring repair are allowed.
- The tear must be fully reparable arthroscopically by a double row technique.
- Final determination of eligibility will be made at surgery when above inclusion criteria are confirmed.
Exclusion
- Prior shoulder surgery (including rotator cuff repair)
- Symptomatic cervical spine disease
- A frozen shoulder-- defined as a loss of passive range of motion (ROM) of more than 20° in any plane compared to the contralateral shoulder,
- Glenohumeral arthritis grade 3 or 4-- defined as full thickness cartilage loss on MRI and confirmed at arthroscopy
- Worker's compensation cases
- Subscapularis tears of any size that require repair
Key Trial Info
Start Date :
September 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT02716441
Start Date
September 1 2016
End Date
April 1 2026
Last Update
August 26 2025
Active Locations (1)
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1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195