Recruiting

Phase 1

Phase 2

Tuberoplasty vs. Balloon SpacerTuberoplasty Versus Balloon Spacer

Sponsor:

University of Minnesota

Code:

NCT06735170

Conditions

Rotator Cuff Tears

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

biologic tuberoplasty

subacromial balloon spacer

Study Details

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

Study ID

NCT06735170

Start date

Dec 2, 2024

Status verified date

Jan, 2026

Completion date

Nov 26, 2026

Anticipated

Primary completion date

Nov 26, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: subacromial balloon spacer group

Interventions

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

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 measure

change in bone-to-bone contact between tuberosity and acromion [ Time Frame: presurgery, 6 months postop, 12 months postop ]
shoulder range of motion [ Time Frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively ]
single assessment numerical evaluation (SANE) of the shoulder [ Time Frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively ]
American shoulder and elbow surgeons (ASES) score [ Time Frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively ]

Central Contacts and Locations

Central contacts

Allison Rao

608-445-0545 rao00149@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Allison Rao

608-445-0545 rao00149@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

rotator cuff tear
shoulder surgery
tuberoplasty
subacromial balloon spacer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-01-07.