Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2024-12-02
2026-11-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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biologic tuberoplasty group
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.
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
subacromial balloon spacer group
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.
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Allison Rao
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Allison Rao
Role: primary
Other Identifiers
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ORTHOSURG-2024-33151
Identifier Type: -
Identifier Source: org_study_id