Tuberoplasty Versus Balloon Spacer

Description

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

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Study Overview

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Study Details

Study overview

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.

Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears

Tuberoplasty Versus Balloon Spacer

Condition
Rotator Cuff Tears
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

Allison Rao, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2026-11-26