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NCT04742452 · ClinicalTrials.gov registry record · NA
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
A NA study of Rotator Cuff Tears, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 105
- Enrollment target
- 3
- Study locations
NCT04742452 is a NA study of Rotator Cuff Tears that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 105 participants, below the 1,276-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT04742452, a NA study of Rotator Cuff Tears, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary objective of this prospective randomized controlled trial is to compare pain and functional outcomes between two surgical modalities for irreparable rotator cuff tears as measured by the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES), and Patient Reported Outcomes Measurement Information System (PROMIS) 29 score at 6 weeks, 3, 6, 12, and 24 months post-operatively. The two surgical modalities of interest are partial rotator cuff repair alone and partial rotator cuff repair with superior capsule reconstruction (SCR). The secondary objective of this study is determine the failure rate of partial repair alone vs. partial repair with SCR via magnetic resonance imaging (MRI) at 12 months post-operatively. The information gained from this investigation will be useful to discern if SCR provides any benefit to patients with irreparable rotator cuff tears. The investigators hypothesize that there is no statistically significant difference in pain and functional outcomes between partial rotator cuff repair alone versus partial rotator cuff repair with SCR. In addition, the investigators hypothesize that the failure rate will be significantly higher in patients undergoing partial rotator cuff repair with SCR.
Conditions Studied
Interventions
- PROCEDURE Superior Capusular Reconstruction
- PROCEDURE Partial Rotator Cuff Repair
Study Locations (3)
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- Lake Health - Willoughby
Illinois
- Midwest Orthopaedics at Rush - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2026-06-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04742452
The ClinicalTrials.gov registry entry for NCT04742452 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,276-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (92% lower). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rotator Cuff Tears appearing as the primary indexed condition, and to 2 interventions - of which Superior Capusular Reconstruction is the first listed.
NCT04742452 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Ohio, Illinois.
Frequently Asked Questions
What is clinical trial NCT04742452 about?
NCT04742452 is a clinical study titled "Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears". The primary objective of this prospective randomized controlled trial is to compare pain and functional outcomes between two surgical modalities for irreparable rotator cuff tears as measured by the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoul...
What is the current status of trial NCT04742452?
This trial is currently recruiting. It is a NA study. The enrollment target is 105 participants. The study started on 2020-11-24. Estimated completion is 2026-06-01.
What conditions does trial NCT04742452 study?
This clinical trial studies the following conditions: Rotator Cuff Tears.
What interventions are being tested in trial NCT04742452?
The interventions under investigation include: Superior Capusular Reconstruction (PROCEDURE), Partial Rotator Cuff Repair (PROCEDURE).
Who is sponsoring clinical trial NCT04742452?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04742452 being conducted?
This trial has 3 study locations across Illinois, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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