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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| biologic tuberoplasty group | Experimental | massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus, no involvement of the subscapularis, centered humeral head on X-Ray examination, and a primary complaint of pain, randomized to biologic tuberoplasty surgery. |
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| subacromial balloon spacer group | Experimental | massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus, no involvement of the subscapularis, centered humeral head on X-Ray examination, and a primary complaint of pain, randomized to subacromial balloon spacer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change 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 | 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 | 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. | 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. | presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Rao | Contact | 608-445-0545 | rao00149@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Allison Rao | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55414 | United States |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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two armed study with each arm receiving one of two interventions: biologic tuberoplasty procedure or subacromial balloon spacer
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| 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 |
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