Rotator Cuff Failure With Continuity
Running, not enrolling
Conditions studied: Rotator Cuff Tear
In brief
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 away from the bone with or without a defect - as a common and clinically predictive structural outcome following rotator cuff repair. The investigators' central hypothesis is that failure with continuity is a common yet unrecognized structural phenomenon of rotator cuff healing that is significantly and meaningfully correlated with clinical outcomes. The investigators' approach is to characterize tendon retraction using an array of implanted radio-opaque markers, and investigate its relationship to pre-operative tissue quality (MRI), post-operative repair structural integrity (MRI) and clinical outcomes in a 125-patient prospective cohort study. These patients will complete (1) validated questionnaires and range of motion testing pre-operatively, (2) CT imaging at day of surgery, 3 weeks, 3 and 6 months, and 1, 2 and 5 years post-operatively, (3) MRI at 3 weeks, 3 and 6 months, and 1, 2 and 5 years post-operatively and (4) questionnaires, range of motion and strength testing at 3 and 6 months and 1, 2 and 5 years post-operatively.
Key facts
- Study ID
- NCT02716441
- Run by
- The Cleveland Clinic
- People needed
- 125
- Starts
- 2016-09-01
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-05-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Cleveland Clinic Main Campus — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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