CompletedNot Applicable

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

United States4 participantsStarted 2018-12-01

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Function of Subscapularis muscle as measured by belly-press test

Timeframe: 5 years

Radiographic loosening

Timeframe: 5 years

Trial details

NCT IDNCT03735173

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-07

View on ClinicalTrials.gov More Arthropathy Shoulder trials