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Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis

NCT06513559 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Glenohumeral Osteoarthritis

Interventions

DEVICE

Anatomic total shoulder replacement

Humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component.

DEVICE

Reverse total shoulder replacement

Polyethylene socket on the humeral side and the glenosphere going on the glenoid side.

Sponsors & Collaborators

Principal Investigators

  • Christopher Joyce, M.D. · University of Utah Orthopaedics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-02
Primary Completion
2024-10-30
Completion
2024-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06513559 on ClinicalTrials.gov