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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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
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
University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGchange in bone-to-bone contact between tuberosity and acromion
degree of change in bone-to-bone contact between tuberosity and acromion as assessed using biplanar fluoroscopy
Time frame: presurgery, 6 months postop, 12 months postop
shoulder range of motion
quantitative measurement in degrees with a goniometer of shoulder motion in forward elevation, abduction, external rotation, and internal rotation
Time frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
single assessment numerical evaluation (SANE) of the shoulder
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.
Time frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
American shoulder and elbow surgeons (ASES) score
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.
Time frame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
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