Actively Recruiting
Tuberoplasty Versus Balloon Spacer
Led by University of Minnesota · Updated on 2026-01-07
40
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Tuberoplasty Versus Balloon Spacer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Involvement of the subscapularis
- Acromiohumeral distance less than 7 mm on upright anterior-posterior 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
A
Allison Rao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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