Tuberoplasty Versus Balloon Spacer

NCT06735170 | Recruiting Phase 1

• 1 other identifier: ORTHOSURG-2024-33151
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Keywords

rotator cuff tear; shoulder surgery; tuberoplasty; subacromial balloon spacer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

biologic tuberoplasty group

EXPERIMENTAL

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

subacromial balloon spacer group

EXPERIMENTAL

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

Interventions

biologic tuberoplasty PROCEDURE

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

biologic tuberoplasty group

subacromial balloon spacer PROCEDURE

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

subacromial balloon spacer group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Allison Rao

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Rao

CONTACT

608-445-0545; rao00149@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two armed study with each arm receiving one of two interventions: biologic tuberoplasty procedure or subacromial balloon spacer

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 16, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)