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

Primary Purpose

Arthropathy Shoulder, Shoulder Pain, Shoulder Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReUnion TSA, pegged design
ReUnion TSA, keeled design
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy Shoulder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Pegged through SP

Pegged through ST

Keeled through SP

Keeled through ST

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Function of Subscapularis muscle as measured by belly-press test
Radiographic loosening
"glenoid at risk" proportion

Secondary Outcome Measures

Full Information

First Posted
October 4, 2018
Last Updated
August 5, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03735173
Brief Title
Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
Official Title
Randomized Clinical Trial Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
May 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy Shoulder, Shoulder Pain, Shoulder Osteoarthritis, Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions, Necrosis of Bone, Arthritis, Inflammatory Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pegged through SP
Arm Type
Active Comparator
Arm Description
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through a Subscapularis Peel (SP) manipulation.
Arm Title
Pegged through ST
Arm Type
Active Comparator
Arm Description
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation.
Arm Title
Keeled through SP
Arm Type
Active Comparator
Arm Description
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through a Subscapularis Peel (SP) manipulation.
Arm Title
Keeled through ST
Arm Type
Active Comparator
Arm Description
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation.
Intervention Type
Procedure
Intervention Name(s)
ReUnion TSA, pegged design
Intervention Description
ReUnion total shoulder arthroplasty system, pegged design
Intervention Type
Procedure
Intervention Name(s)
ReUnion TSA, keeled design
Intervention Description
ReUnion total shoulder arthroplasty system, keeled design
Primary Outcome Measure Information:
Title
Function of Subscapularis muscle as measured by belly-press test
Time Frame
5 years
Title
Radiographic loosening
Description
"glenoid at risk" proportion
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Morrey, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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