Tuberoplasty Versus Balloon Spacer for Rotator Cuff Tears
This study is looking at two surgical procedures for massive, irreparable rotator cuff tears (a tear in the group of muscles and tendons that surround the shoulder joint). You might be eligible if you are 65 or older, have a massive tear involving specific shoulder muscles (supraspinatus and infraspinatus), experience pain, and have had previous shoulder surgery. The study aims to see if either "biologic tuberoplasty" (attaching a special tissue graft to the shoulder bone) or a "subacromial balloon spacer" (inserting a biodegradable balloon into the shoulder joint) can reduce bone-on-bone contact and pain. Researchers will measure changes in bone contact, shoulder movement, and your pain levels over 12 months. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 40 participants. It compares two surgical procedures for rotator cuff tears.
- What's involved
- You would have measurements taken before surgery, then at 1 week, 6 weeks, 3 months, 6 months, and 12 months after surgery. These measurements include shoulder range of motion and pain assessment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after their surgery to assess changes in bone contact, shoulder movement, and pain.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Tuberoplasty Versus Balloon Spacer
At a glance
Conditions
NCT06735170
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Minnesota
Minneapolis, Minnesotastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Allison Rao · PRINCIPAL_INVESTIGATOR · University of Minnesota
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- change in bone-to-bone contact between tuberosity and acromionpresurgery, 6 months postop, 12 months postop
degree of change in bone-to-bone contact between tuberosity and acromion as assessed using biplanar fluoroscopy
- shoulder range of motionpresurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
quantitative measurement in degrees with a goniometer of shoulder motion in forward elevation, abduction, external rotation, and internal rotation
- single assessment numerical evaluation (SANE) of the shoulderpresurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
a validated tool providing a numerical score from 0-100 that assess shoulder function as subjectively reported by the subject. A higher score indicates superior shoulder function.
- American shoulder and elbow surgeons (ASES) scorepresurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
a validated survey with possible scores from 0-100 that assesses shoulder function as reported by the subject. A higher score indicates superior shoulder function.