Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty
NCT ID: NCT02768597
Last Updated: 2024-02-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
113 participants
INTERVENTIONAL
2016-04-30
2022-12-15
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
TREATMENT
NONE
Study Groups
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Large-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
ReUnion System with a Large-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
Small-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
ReUnion System with a Small-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
Large-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
ReUnion System with a Large-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
Small-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset
ReUnion System with a Small-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset
Interventions
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ReUnion System with a Large-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
ReUnion System with a Small-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
ReUnion System with a Large-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
ReUnion System with a Small-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset
Eligibility Criteria
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Inclusion Criteria
* Male and non-pregnant female subjects ages 50 - 90 at the time of surgery
* Subjects requiring a primary reverse total shoulder arthroplasty
* Subjects with the diagnosis of cuff-tear arthropathy (CTA), massive irreparable rotator cuff tear (MRCT) or osteoarthritis (OA) with marked posterior subluxation or bone loss
Exclusion Criteria
* Subjects with inflammatory arthritis
* Subjects with proximal humerus fractures
* Subjects with sequels of trauma
* Subjects that are immunologically compromised
* Subjects with an active or suspected latent infection in or about the shoulder
* Need to add a tendon transfer
* Need for structural humeral bone graft
* Pregnant subjects
50 Years
90 Years
ALL
No
Sponsors
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Stryker Nordic
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Mark E. Morrey, M.D.
Principal Investigator
Principal Investigators
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Mark Morrey, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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15-006839
Identifier Type: -
Identifier Source: org_study_id
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