Tuberoplasty Versus Balloon Spacer

Phase 1

Recruiting

• Conditions: Rotator Cuff Tears

• Registration Number: NCT06735170
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-02
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-11-26
• Study Completion: 2026-11-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in bone-to-bone contact between tuberosity and acromion	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	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	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	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States