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Completed

NCT Number: NCT03735173

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

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.

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Key information

Conditions

Arthropathy Shoulder Arthralgia Arthritis Bone Diseases Inflammatory Arthritis Joint Diseases Musculoskeletal Diseases Necrosis Necrosis of Bone Neurologic Manifestations Osteonecrosis Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Shoulder Arthritis Shoulder Arthropathy Associated With Other Conditions Shoulder Osteoarthritis Shoulder Pain Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReUnion TSA, pegged design

Procedure

ReUnion total shoulder arthroplasty system, pegged design

ReUnion TSA, keeled design

Procedure

ReUnion total shoulder arthroplasty system, keeled design

Primary outcomes

  1. Function of Subscapularis muscle as measured by belly-press test

    Time frame: 5 years

  2. Radiographic loosening

    Time frame: 5 years

    "glenoid at risk" proportion

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2018
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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