Arthritis, Arthropathy Shoulder, Inflammatory Arthritis, Necrosis of Bone, Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions, Shoulder Osteoarthritis, Shoulder Pain
Conditions
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.
Interventions
PROCEDUREReUnion TSA, pegged design
ReUnion total shoulder arthroplasty system, pegged design
PROCEDUREReUnion TSA, keeled design
ReUnion total shoulder arthroplasty system, keeled design
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Function of Subscapularis muscle as measured by belly-press test | 5 years | — |
| Radiographic loosening | 5 years | glenoid at risk proportion |
Countries
United States
Outcome results
None listed