RecruitingPhase 1Phase 2NCT06735170

Tuberoplasty Versus Balloon Spacer

Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears

Sponsor

University of Minnesota

Enrollment

40 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Rotator Cuff Tears

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical treatments for people with large, irreparable rotator cuff tears in the shoulder — a procedure called tuberoplasty (which smooths the bone surface and may use a tissue graft) versus a subacromial balloon spacer (an implant that cushions the joint). Using specialized motion capture technology, researchers will measure how each procedure affects bone contact in the shoulder and patient-reported pain and function. Adults aged 65 and older whose rotator cuff tear involves the supraspinatus and infraspinatus tendons, has failed previous repair, and presents primarily as pain may be eligible if the humeral head remains centered. Participation involves undergoing one of the two procedures and attending follow-up visits for motion analysis and questionnaires. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREbiologic 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

PROCEDUREsubacromial 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