Image

Tuberoplasty Versus Balloon Spacer

Tuberoplasty Versus Balloon Spacer

Recruiting
65 years and older
All
Phase 1/2

Powered by AI

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.

Eligibility

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 details
    Rotator Cuff Tears

NCT06735170

University of Minnesota

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.