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RECRUITING
NCT06735170
PHASE1/PHASE2

Tuberoplasty Versus Balloon Spacer

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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.

Official title: Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-12-02

Completion Date

2026-11-26

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States