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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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-09-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Interpositional Group
Demineralized bone matrix
Demineralized bone matrix
Demineralized bone matrix
Control
Without demineralized bone matrix
No interventions assigned to this group
Interventions
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Demineralized bone matrix
Demineralized bone matrix
Eligibility Criteria
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Inclusion Criteria
* Subject is planning to undergo arthroscopic surgery for full thickness rotator cuff tears (RCT) of supraspinatus and infraspinatus muscles, who are candidates for demineralized bone matrix with BMC.
* Two tendon tear or tear size equal to or greater than 3cm
* Amenable to double-row repair
* Primary rotator cuff tears with or without superior labral tear and/or biceps tear)
Exclusion Criteria
* The Subject objects to use of allograft
* Irreparable Rotator Cuff Tear
* Complete full thickness subscapularis tears of \> than the superior 1/3 of the tendon (Lafosse grade 3 and above)
* \< 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
* Recurrent shoulder instability
* Intra-articular injections (steroids) within 1 month of surgery
* RCR revisions
* Subject MRI taken more than 12 months prior to surgery
* Pregnant or planning to become pregnant during the study period
* Workman's compensation case
40 Years
75 Years
ALL
Yes
Sponsors
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Arthrex, Inc.
INDUSTRY
Responsible Party
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Locations
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Southern Oregon Orthopedics
Medford, Oregon, United States
Countries
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Other Identifiers
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US-1300
Identifier Type: -
Identifier Source: org_study_id
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