Tuberoplasty Versus Balloon Spacer
Recruiting now · Phase 1/Phase 2
Conditions studied: Rotator Cuff Tears
In brief
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.
Key facts
- Study ID
- NCT06735170
- Run by
- University of Minnesota
- People needed
- 40
- Starts
- 2024-12-02
- Expected to finish
- 2026-11-26
- Last updated by the study team
- 2026-01-07
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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 is running
- University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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