NCT06735170 · University of Minnesota
Tuberoplasty Versus Balloon Spacer
What this study is about
The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure.
View original scientific description
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.
Interventions
PROCEDURE
biologic tuberoplasty
a surgical procedure during which an a cellular dermal allograft is attached to the greater tuberosity to prevent bone-to-bone contact between the greater tuberosity and the acromion with the goal of decreasing pain
PROCEDURE
subacromial balloon spacer
a biodegradable balloon is inserted into the subacromial space of the shoulder to increase teh distance between the greater tuberosity and the acromion to reduce pain
Primary outcome measures
change in bone-to-bone contact between tuberosity and acromion
Time frame: presurgery, 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 motion
Time frame: presurgery, 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 shoulder
Time frame: presurgery, 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) score
Time frame: presurgery, 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 criteria
- 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
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations