Rotator Cuff Tears
Conditions
Keywords
rotator cuff tear, shoulder surgery, tuberoplasty, subacromial balloon spacer
Brief summary
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
PROCEDUREbiologic 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
PROCEDUREsubacromial 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
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
two armed study with each arm receiving one of two interventions: biologic tuberoplasty procedure or subacromial balloon spacer
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in bone-to-bone contact between tuberosity and acromion | presurgery, 6 months postop, 12 months postop | degree of change in bone-to-bone contact between tuberosity and acromion as assessed using biplanar fluoroscopy |
| shoulder range of motion | 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 |
| single assessment numerical evaluation (SANE) of the shoulder | 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. |
| American shoulder and elbow surgeons (ASES) score | 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. |
Countries
United States
Contacts
Primary ContactAllison Rao
Outcome results
None listed