Tuberoplasty Versus Balloon Spacer (NCT06735170)
Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Minnesota โ Minneapolis, Minnesota
Age range: 65 Years
๐งช Interventions in This Study
- biologic tuberoplasty (PROCEDURE)
- subacromial balloon spacer (PROCEDURE)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- University of Minnesota โ Minneapolis, Minnesota
๐ Contact the Study Coordinator
Phone: (608) 445-0545
Email: rao00149@umn.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rotator Cuff Tears
- E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults โ New York, New York
- Variation in Humeral Head Bone Marrow Characteristics With Rotator Cuff Repair Healing โ Cleveland, Ohio
- Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease โ Great Neck, New York
- Shoulder iDโข Primary Reversed Glenoid Outcomes Clinical Study โ San Francisco, California
- MRI Evaluation of Integrity Implant for Rotator Cuff Tears โ Tampa, Florida
- Maximal Repair Versus Bridging Reconstruction with BioBraceยฎ โ Halifax, Nova Scotia
Explore by condition: All Rotator Cuff Tears clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.