Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
NCT ID: NCT03735173
Last Updated: 2021-08-12
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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COMPLETED
NA
4 participants
INTERVENTIONAL
2018-12-01
2021-05-07
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
SINGLE
Study Groups
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Pegged through SP
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through a Subscapularis Peel (SP) manipulation.
ReUnion TSA, pegged design
ReUnion total shoulder arthroplasty system, pegged design
Pegged through ST
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation.
ReUnion TSA, pegged design
ReUnion total shoulder arthroplasty system, pegged design
Keeled through SP
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through a Subscapularis Peel (SP) manipulation.
ReUnion TSA, keeled design
ReUnion total shoulder arthroplasty system, keeled design
Keeled through ST
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation.
ReUnion TSA, keeled design
ReUnion total shoulder arthroplasty system, keeled design
Interventions
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ReUnion TSA, pegged design
ReUnion total shoulder arthroplasty system, pegged design
ReUnion TSA, keeled design
ReUnion total shoulder arthroplasty system, keeled design
Eligibility Criteria
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Inclusion Criteria
* Male and female subjects ages 18 - 90 at the time of surgery
* Subjects indicated for an anatomic total shoulder arthroplasty (including primary glenohumeral osteoarthritis, avascular necrosis, and inflammatory arthritis)
Exclusion Criteria
* Known or presumed substantial rotator cuff disorders
* Subjects with an active or suspected latent infection in or about the shoulder
* Subjects with instability (surgically or non-surgically addressed)
* Subjects presenting with posttraumatic avascular necrosis
* Need for glenoid bone grafting
* Pregnant subjects
18 Years
90 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mark E. Morrey, M.D.
Principal Investigator
Principal Investigators
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Mark Morrey, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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17-011251
Identifier Type: -
Identifier Source: org_study_id
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