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

Mayo Clinic

Status: Completed

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

Treatments: Procedure: ReUnion TSA, pegged design; Procedure: ReUnion TSA, keeled design

Study type: Interventional

Funder types: Other

Identifiers

NCT03735173

17-011251

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 4 patient groups

Pegged through SP

Active Comparator group

Description:

Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through a Subscapularis Peel (SP) manipulation.

Treatment:

Procedure: ReUnion TSA, pegged design

Pegged through ST

Active Comparator group

Description:

Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation.

Treatment:

Procedure: ReUnion TSA, pegged design

Keeled through SP

Active Comparator group

Description:

Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through a Subscapularis Peel (SP) manipulation.

Treatment:

Procedure: ReUnion TSA, keeled design

Keeled through ST

Active Comparator group

Description:

Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation.

Treatment:

Procedure: ReUnion TSA, keeled design