Tuberoplasty Versus Balloon Spacer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: biologic tuberoplasty, subacromial balloon spacer.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears
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.
Interventions
- Procedure biologic tuberoplasty
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 - Procedure subacromial balloon spacer
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 outcome measures
- change in bone-to-bone contact between tuberosity and acromion [Time frame: presurgery, 6 months postop, 12 months postop]
- shoulder range of motion [Time frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively]
- single assessment numerical evaluation (SANE) of the shoulder [Time frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively]
- American shoulder and elbow surgeons (ASES) score [Time frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT06735170 · ORTHOSURG-2024-33151