Tuberoplasty vs Balloon Spacer for Rotator Cuff Tears
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
Who this trial is looking for
This trial is looking for people with large rotator cuff tears who have had pain and possibly previous surgeries. Participants will help researchers compare two different treatments to see how well they work for shoulder function and pain relief.
Are You a Good Fit for This Trial?
You may be able to join if
- I have a massive rotator cuff tear.
- I have pain as my main complaint.
- I have had previous surgery on my shoulder.
- I have not had a successful rotator cuff repair.
You may not be able to join if
- I have a tear involving the subscapularis.
- My shoulder joint shows less than 7 mm of space on x-ray.
- My rotator cuff can be repaired.
- I am younger than 65 years old.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
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