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

NCT03735173 | Completed

• 1 other identifier: 17-011251
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Function of Subscapularis muscle as measured by belly-press test

  5 years

• Radiographic loosening

  "glenoid at risk" proportion

  5 years

Study Arms (4)

Pegged through SP

ACTIVE COMPARATOR

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

Procedure: ReUnion TSA, pegged design

Pegged through ST

ACTIVE COMPARATOR

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

Procedure: ReUnion TSA, pegged design

Keeled through SP

ACTIVE COMPARATOR

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

Procedure: ReUnion TSA, keeled design

Keeled through ST

ACTIVE COMPARATOR

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

Procedure: ReUnion TSA, keeled design

Interventions

ReUnion TSA, pegged design PROCEDURE

ReUnion total shoulder arthroplasty system, pegged design

Pegged through SP; Pegged through ST

ReUnion TSA, keeled design PROCEDURE

ReUnion total shoulder arthroplasty system, keeled design

Keeled through SP; Keeled through ST

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Shoulder Pain; Osteonecrosis; Arthritis

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Necrosis; Pathologic Processes

Study Officials

• Mark Morrey, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: November 8, 2018
• Study Start: December 1, 2018
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

US (1)