Tuberoplasty Versus Balloon Spacer
Recruiting
Phase 1
Phase 2
Interventional Study
Rotator Cuff Tears
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 65 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- University of Minnesota · Other
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About This Trial
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 p…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion C…
Contacts