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

August 5, 2021 updated by: Mark E. Morrey, M.D., Mayo Clinic

Randomized Clinical Trial 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pegged through SP
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
ReUnion total shoulder arthroplasty system, pegged design
ACTIVE_COMPARATOR: Pegged through ST
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation.
Procedure: ReUnion TSA, pegged design
ReUnion total shoulder arthroplasty system, pegged design
ACTIVE_COMPARATOR: Keeled through SP
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
ReUnion total shoulder arthroplasty system, keeled design
ACTIVE_COMPARATOR: Keeled through ST
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation.
Procedure: ReUnion TSA, keeled design
ReUnion total shoulder arthroplasty system, keeled design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function of Subscapularis muscle as measured by belly-press test
Time Frame: 5 years
5 years
Radiographic loosening
Time Frame: 5 years
"glenoid at risk" proportion
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

May 7, 2021

Study Completion (ACTUAL)

May 7, 2021

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (ACTUAL)

November 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-011251

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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