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 Bone; Arthropathy Shoulder; Shoulder Osteoarthritis; Shoulder Arthritis; Arthritis; Inflammatory Arthritis; Shoulder Pain; Shoulder Arthropathy Associated With Other Conditions
• Interventions: Procedure: ReUnion TSA, pegged design; Procedure: ReUnion TSA, keeled design

• 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

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-08
• Study Start: 2018-12-01
• Primary Completion: 2021-05-07
• Study Completion: 2021-05-07
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-12

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

Arm && Interventions

Group	Intervention	Description
Pegged through SP	ReUnion TSA, pegged design	Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through a Subscapularis Peel (SP) manipulation.
Pegged through ST	ReUnion TSA, pegged design	Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation.
Keeled through SP	ReUnion TSA, keeled design	Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through a Subscapularis Peel (SP) manipulation.
Keeled through ST	ReUnion TSA, keeled design	Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation.

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States