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NCT02716441 · ClinicalTrials.gov registry record
Rotator Cuff Failure With Continuity
A clinical trial of Rotator Cuff Tear, sponsored by The Cleveland Clinic.
- Active
- Registry status
- 125
- Enrollment target
- 1
- Study location
NCT02716441 is a study of Rotator Cuff Tear that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 125 participants, above the 82-participant average among 11 other Rotator Cuff Tear trials with a reported enrollment target (52% higher). The trial reports 1 study location across 1 state.
The verdict
NCT02716441, a study of Rotator Cuff Tear, is active but no longer recruiting, sponsored by The Cleveland Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- 125 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DEVICE Radio-opaque Tissue Markers
Study Locations (1)
Ohio
- Cleveland Clinic Main Campus - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2016-09 |
| Est. Completion | 2026-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02716441
The ClinicalTrials.gov registry entry for NCT02716441 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 82-participant average among 11 other Rotator Cuff Tear trials with a reported enrollment target (52% higher). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rotator Cuff Tear appearing as the primary indexed condition, and to 1 intervention - of which Radio-opaque Tissue Markers is the first listed.
NCT02716441 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT02716441 about?
NCT02716441 is a clinical study titled "Rotator Cuff Failure With Continuity". 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...
What is the current status of trial NCT02716441?
This trial is currently active not recruiting. The enrollment target is 125 participants. The study started on 2016-09. Estimated completion is 2026-04.
What conditions does trial NCT02716441 study?
This clinical trial studies the following conditions: Rotator Cuff Tear.
What interventions are being tested in trial NCT02716441?
The interventions under investigation include: Radio-opaque Tissue Markers (DEVICE).
Who is sponsoring clinical trial NCT02716441?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02716441 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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