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Rotator Cuff Failure With Continuity

NCT02716441 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tear

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Kathleen Derwin, PhD · The Cleveland Clinic

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02716441 on ClinicalTrials.gov