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ACTIVE NOT RECRUITING
NCT02716441

Rotator Cuff Failure With Continuity

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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 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.

Official title: Failure With Continuity and Its Relation to Rotator Cuff Repair Clinical Outcomes

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

125

Start Date

2016-09

Completion Date

2026-04

Last Updated

2025-08-26

Healthy Volunteers

No

Interventions

DEVICE

Radio-opaque Tissue Markers

All participants will undergo implantation of radio-opaque tissue markers on their repaired rotator cuff at the time of surgery.

Locations (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, United States