Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
Not Applicable
Completed
- Conditions
- Necrosis of BoneArthropathy ShoulderShoulder OsteoarthritisShoulder ArthritisArthritisInflammatory ArthritisShoulder PainShoulder Arthropathy Associated With Other Conditions
- Registration Number
- NCT03735173
- Lead Sponsor
- Mayo Clinic
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Radiographic loosening 5 years "glenoid at risk" proportion
Function of Subscapularis muscle as measured by belly-press test 5 years
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of subscapularis tenotomy versus peel repair in shoulder arthropathy?
How does the pegged design compare to keeled components in cemented all-polyethylene total shoulder arthroplasty?
What biomarkers predict successful subscapularis repair outcomes in shoulder osteoarthritis patients?
What are the potential adverse events associated with subscapularis tenotomy in cemented TSA procedures?
How does ReUnion TSA compare to standard-of-care total shoulder arthroplasty in managing inflammatory shoulder arthritis?
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Mayo Clinic🇺🇸Rochester, Minnesota, United States