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NCT Number: NCT06735170

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 (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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Allison Rao

CONTACT

[email protected]

608-445-0545

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biologic tuberoplasty

Procedure

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

Procedure

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 outcomes

  1. change in bone-to-bone contact between tuberosity and acromion

    Time frame: presurgery, 6 months postop, 12 months postop

    degree of change in bone-to-bone contact between tuberosity and acromion as assessed using biplanar fluoroscopy

  2. shoulder range of motion

    Time frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively

    quantitative measurement in degrees with a goniometer of shoulder motion in forward elevation, abduction, external rotation, and internal rotation

  3. single assessment numerical evaluation (SANE) of the shoulder

    Time frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively

    a validated tool providing a numerical score from 0-100 that assess shoulder function as subjectively reported by the subject. A higher score indicates superior shoulder function.

  4. American shoulder and elbow surgeons (ASES) score

    Time frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively

    a validated survey with possible scores from 0-100 that assesses shoulder function as reported by the subject. A higher score indicates superior shoulder function.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Rao

CONTACT

[email protected]

608-445-0545

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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