RECRUITING

Tuberoplasty Versus Balloon Spacer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears

Quick Facts

Study Start:2024-12-02
Study Completion:2026-11-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06735170

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.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus.
  2. * No involvement of the subscapularis.
  3. * Centered humeral head on X-ray examination.
  4. * Primary complaint of pain.
  5. * History of prior surgery, including failed rotator cuff repair.
  1. * Involvement of the subscapularis.
  2. * Acromiohumeral distance less than 7 mm on upright anterior-posterior (AP) radiograph.
  3. * Rotator cuff deemed repairable at the time of surgery.
  4. * Patients younger than 65 years due to FDA clearance of the subacromial balloon spacer only for patients over 65

Contacts and Locations

Study Contact

Allison Rao
CONTACT
608-445-0545
rao00149@umn.edu

Principal Investigator

Allison Rao
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Allison Rao, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-02
Study Completion Date2026-11-26

Study Record Updates

Study Start Date2024-12-02
Study Completion Date2026-11-26

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Rotator Cuff Tears