Tuberoplasty Versus Balloon Spacer

Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: biologic tuberoplasty; Procedure: subacromial balloon spacer

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Allison Rao; Phone Number: 608-445-0545; Email: rao00149@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Allison Rao; Phone Number: 608-445-0545; Email: rao00149@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: biologic tuberoplasty group; massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus, no involvement of the subscapularis, centered humeral head on X-Ray examination, and a primary complaint of pain, randomized to biologic tuberoplasty surgery.	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
Experimental: subacromial balloon spacer group; massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus, no involvement of the subscapularis, centered humeral head on X-Ray examination, and a primary complaint of pain, randomized to subacromial balloon spacer.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in bone-to-bone contact between tuberosity and acromion	degree of change in bone-to-bone contact between tuberosity and acromion as assessed using biplanar fluoroscopy	presurgery, 6 months postop, 12 months postop
shoulder range of motion	quantitative measurement in degrees with a goniometer of shoulder motion in forward elevation, abduction, external rotation, and internal rotation	presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
single assessment numerical evaluation (SANE) of the shoulder	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.	presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
American shoulder and elbow surgeons (ASES) score	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.	presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Allison Rao, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: rotator cuff tear; shoulder surgery; tuberoplasty; subacromial balloon spacer
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: ORTHOSURG-2024-33151

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No