Comparing tuberoplasty and balloon spacer for rotator cuff tears
Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears
This study is testing whether a new shoulder procedure called tuberoplasty works better than a balloon spacer for people with large, irreparable rotator cuff tears to see how it affects their pain and ability to move their arm.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06735170 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of tuberoplasty versus a subacromial balloon spacer in patients with massive irreparable rotator cuff tears. Using biplanar fluoroscopy, the researchers will assess bone-to-bone contact and shoulder motion before and after the procedures. The study aims to determine how these interventions affect arm elevation and scapulothoracic motion, while also correlating findings with patient-reported outcomes related to pain and shoulder function.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 and older with massive irreparable rotator cuff tears involving the supraspinatus and infraspinatus.
Not a fit: Patients with repairable rotator cuff tears or those with subscapularis involvement will 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 severe rotator cuff injuries, potentially improving their pain and functional outcomes.
How similar studies have performed: While there have been studies on rotator cuff repairs, this specific comparison of tuberoplasty and balloon spacer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus. * No involvement of the subscapularis. * Centered humeral head on X-ray examination. * Primary complaint of pain. * History of prior surgery, including failed rotator cuff repair. Exclusion Criteria: * Involvement of the subscapularis. * Acromiohumeral distance less than 7 mm on upright anterior-posterior (AP) radiograph. * Rotator cuff deemed repairable at the time of surgery. * Patients younger than 65 years due to FDA clearance of the subacromial balloon spacer only for patients over 65
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Allison Rao — University of Minnesota
- Study coordinator: Allison Rao
- Email: rao00149@umn.edu
- Phone: 608-445-0545
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.