NCT06735170

Tuberoplasty Versus Balloon Spacer

Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. Using biplanar fluoroscopy to determine the three-dimensional (3D) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be able to assess 1) the bone-to-bone contact of the tuberosity and acromion in the setting of a massive posterior superior rotator cuff tear 2) if the placement of a dermal allograft over the tuberosity does indeed decrease bone contact and 3) if the placement of a subacromial balloon spacer decreases bone-to-bone contact. Doing so will allow assessment of the relative contribution of the implant for arm elevation versus potential compensatory motion of increased scapulothoracic motion. The investigators will also be able to correlate this to patient-reported outcomes of pain and shoulder function.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
PROCEDURE	biologic tuberoplasty	a surgical procedure during which an a cellular dermal allograft is attached to the greater tuberosity to prevent bone-to-bone contact between the greater tuberosity and the acromion with the goal of decreasing pain
PROCEDURE	subacromial balloon spacer	a biodegradable balloon is inserted into the subacromial space of the shoulder to increase teh distance between the greater tuberosity and the acromion to reduce pain

Timeline

• Start date: 2024-12-02
• Primary completion: 2026-11-26
• Completion: 2026-11-26
• First posted: 2024-12-16
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States