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Tuberoplasty Versus Balloon Spacer | Clinical Trials | Clareo Health

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RECRUITINGPhase 1/2NCT06735170

Tuberoplasty Versus Balloon Spacer

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...

Lead sponsor: University of Minnesota•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Allison Rao

CONTACT

608-445-0545 rao00149@umn.edu

Sponsors

Lead Sponsor

University of Minnesota

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 7, 2026Terms

Trial snapshot

StatusRECRUITING

PhasePHASE1/PHASE2

Enrollment40

Start dateDec 2024

Last updatedJan 7, 2026

Condition

Rotator Cuff Tears

Locations shown

University of Minnesota

Minneapolis, Minnesota

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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