Comparing two surgical methods for irreparable rotator cuff tears
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
This study is testing whether adding a special reconstruction procedure to a partial rotator cuff repair can help people with irreparable rotator cuff tears feel better and function better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT04742452 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two surgical techniques for treating irreparable rotator cuff tears: partial rotator cuff repair alone and partial rotator cuff repair combined with superior capsular reconstruction (SCR). The study will assess pain and functional outcomes using various scoring systems at multiple time points post-surgery. Additionally, it will evaluate the failure rates of each approach through MRI imaging at 12 months. The goal is to determine if SCR offers any significant benefits over partial repair alone for patients with these challenging injuries.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with irreparable rotator cuff tears confirmed by pre-operative MRI.
Not a fit: Patients with rotator cuff injuries that can be fully repaired or those with severe arthropathy or other complicating factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective surgical options for patients with irreparable rotator cuff tears, potentially improving their pain management and functional recovery.
How similar studies have performed: While there have been various approaches to managing rotator cuff tears, the specific comparison of partial repair with SCR is relatively novel and has shown promising early results in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age range: ≥18 years * Irreparable rotator cuff tear suspected on pre-operative MRI Exclusion Criteria: * Pregnant, illiterate, or non-English speaking individuals * Rotator cuff pathology amenable to a complete repair intraoperatively * Moderate to severe rotator cuff arthropathy (Hamada grade ≥3) * Presence of glenohumeral arthritis on radiographs * Irreparable subscapularis muscle intraoperatively * Active infection within the ipsilateral glenohumeral joint * Neurologic pathology limiting shoulder function * Current smoker * Workers' compensation claim
Where this trial is running
Chicago, Illinois and 2 other locations
- Midwest Orthopaedics at Rush — Chicago, Illinois, United States (Not_yet_recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Lake Health — Willoughby, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: John T Strony, BS
- Email: john.strony@uhhospitals.org
- Phone: 908-268-3663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.