Impact of Humeral Component Version on Outcomes Following RTSA

February 6, 2024 updated by: Michael Wiater, William Beaumont Hospitals

The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial

The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Study Type

Interventional

Enrollment (Actual)

95

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
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Health

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing primary reverse total shoulder arthroplasty
  • Diagnosis of cuff tear arthropathy or primary OA with RCT
  • Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam
  • 18 years or older

Exclusion Criteria:

  • Revision arthroplasty
  • Diagnosis of rheumatoid arthritis, infection, acute trauma or instability

  • Minors (under 18 years of age)

    • Prior open shoulder surgery
    • Concomitant latissimus dorsi transfer
    • Patients not undergoing a standard of care physical therapy protocol
    • Pregnant, patient-reported
    • Cognitively impaired

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0 degrees humeral component version
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
Device: 0 degrees humeral component version
RTSA with humeral component positioned in 0 degrees of version
Experimental: 30 degrees humeral component retroversion
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
Device: 30 degrees humeral component retroversion
RTSA with humeral component positioned in 30 degrees of retroversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative External Range of Motion (ROM)
Time Frame: 2 years
External range of motion measurements of the shoulder in degrees
2 years
Postoperative Internal Range of Motion (ROM)
Time Frame: 2 years
Internal range of motion measurements of the shoulder in degrees
2 years

Collaborators and Investigators

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

Sponsor

William Beaumont Hospitals

Investigators

  • Principal Investigator: J. Michael Wiater, MD, William Beaumont Hospitals

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)

May 12, 2017

Primary Completion (Actual)

May 23, 2023

Study Completion (Actual)

May 23, 2023

Study Registration Dates

First Submitted

April 7, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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