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NCT03735173 Clinical Trial

Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel

Shoulder Pain Clinical Trial

Official title:
Randomized Clinical Trial Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03735173
Other study ID # 17-011251
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date May 7, 2021

Study information
Verified date August 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date May 7, 2021
Est. primary completion date May 7, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Subjects willing to sign the informed consent - 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: - Inability to comply with follow-up requirements - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ReUnion TSA, pegged design
ReUnion total shoulder arthroplasty system, pegged design
• ReUnion TSA, keeled design
ReUnion total shoulder arthroplasty system, keeled design

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Function of Subscapularis muscle as measured by belly-press test 5 years
Primary Radiographic loosening "glenoid at risk" proportion 5 years
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