Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis

February 25, 2025 updated by: Christopher Joyce, University of Utah

Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis: a Randomized Prospective Study

The primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty (RTSA) have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.

The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA.

The devices being used in the research are an Arthrex Universe system (Arthrex Univers Reverse vs Arthrex Apex humeral stem or Eclipse stem with a polyethylene glenoid). They are FDA approved, commonly used, and used as indicated. The anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. The reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side.

In all cases, a deltopectoral incision will be used as the procedure type.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Total anatomic shoulder arthroplasty (TSA) is an effective treatment of severe glenohumeral osteoarthritis, with significant improvement in shoulder pain and function. Concerns about glenoid loosening, associated with difficult revision procedures and disappointing outcomes, have however been raised.

Reverse total shoulder arthroplasty (RTSA) was designed to treat cuff tear arthropathy. Favorable early reports led to the expansion of using RTSA to treat other shoulder fractures as well as osteoarthritis with poor glenoid bone stock. Recent reports revealed excellent clinical results of RTSA for primary glenohumeral arthropathy with intact rotator cuff and a low rate of complications.

Retrospective studies comparing functional results - of anatomic TSA for treating glenohumeral osteoarthritis with RTSA for rotator cuff arthropathy - found equivalent or greater improvements in American Shoulder and Elbow Surgeons score (ASES) at >2-year follow-up. In a study comparing anatomic TSA to RTSA for the treatment of glenohumeral osteoarthritis with intact rotator cuffs, investigators have reported equivalent functional results at >2-year follow-up. However, this study could not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients.The investigators therefore hypothesize that, in patients treated for glenohumeral osteoarthritis, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies have confirmed this hypothesis. Moreover, several studies revealed good long-term survivorship after RTSA.

There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion.

Study Type

Interventional

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
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopedics

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary glenohumeral arthritis,
  • Intact rotator cuff,
  • No important glenoid bone loss (cf exclusion criteria),
  • Patients between 60 and 85 years old (based on indications for RTSA)
  • Informed Consent as documented by signature (Appendix Informed Consent Form).

Exclusion Criteria:

  • B2 glenoid with > 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
  • B3 and C type glenoids,
  • Full thickness rotator cuff tear,
  • Acute or malunited proximal humeral fracture,
  • Chronic locked dislocation
  • Rheumatoid arthritis,
  • Revision surgery or surgical antecedents,
  • Tumors,
  • Axillary nerve damage,
  • Non-functioning deltoid muscle,
  • Glenoid vault deficiency precluding baseplate fixation,
  • Infection and neuropathic joints,
  • Known or suspected non-compliance, drug or alcohol abuse,
  • Patients incapable of judgement or under tutelage,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant,

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anatomic total shoulder replacement
Anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component.
Device: Anatomic total shoulder replacement
Humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component.
Other Names:
  • Arthrex Eclipse stem with a polyethylene glenoid.
  • Stryker perform stem with cortiloc glenoid
  • Enovis CS Edge stem with altivate anatomic glenoid
  • Exactech Equinoxe stem with cage anatomic glenoid
Experimental: Reverse total shoulder replacement
Reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side.
Device: Reverse total shoulder replacement
Polyethylene socket on the humeral side and the glenosphere going on the glenoid side.
Other Names:
  • Arthrex Universe Reverse.
  • Stryker perform reverse
  • Enovis Altivate reverse
  • Exactech Equinoxe reverse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Shoulder and Elbow Surgeons score
Time Frame: date of surgery
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
date of surgery
American Shoulder and Elbow Surgeons score
Time Frame: 6 months after date of surgery
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
6 months after date of surgery
American Shoulder and Elbow Surgeons score
Time Frame: 12 months after date of surgery
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
12 months after date of surgery
American Shoulder and Elbow Surgeons score
Time Frame: 24 months after date of surgery
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
24 months after date of surgery

Collaborators and Investigators

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

Sponsor

University of Utah

Investigators

  • Principal Investigator: Christopher Joyce, M.D., University of Utah Orthopaedics

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)

August 2, 2023

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 159808

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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