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

Mayo Clinic4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Arthropathy Shoulder Shoulder Pain Shoulder Osteoarthritis Shoulder Arthritis Shoulder Arthropathy Associated With Other Conditions Necrosis of Bone

Interventions

ReUnion TSA, pegged designPROCEDURE

ReUnion total shoulder arthroplasty system, pegged design

ReUnion TSA, keeled designPROCEDURE

ReUnion total shoulder arthroplasty system, keeled design

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Function of Subscapularis muscle as measured by belly-press test

Time frame: 5 years

Radiographic loosening

"glenoid at risk" proportion