Comparing tuberoplasty and balloon spacer for rotator cuff tears

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.