NCT06735170 Tuberoplasty Versus Balloon Spacer
| NCT ID | NCT06735170 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Minnesota |
| Condition | Rotator Cuff Tears |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-11-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-12-02 with a primary completion date of 2026-11-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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
Contact & Investigator
Allison Rao
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06735170 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Rotator Cuff Tears. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06735170 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06735170 currently recruiting?
Yes, NCT06735170 is actively recruiting participants. Contact the research team at rao00149@umn.edu for enrollment information.
Where is the NCT06735170 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06735170 clinical trial?
NCT06735170 is sponsored by University of Minnesota. The principal investigator is Allison Rao at University of Minnesota. The trial plans to enroll 40 participants.