Pyrocarbon Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis

Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis: The Impact of Modern Implant Options

This is a multi-center study assessing postoperative outcomes associated with hemiarthroplasty with pyrocarbon (hPYC) versus anatomic total shoulder arthroplasty (aTSA). Once eligibility criteria is met, the subject will be randomized to one of the two study arms. Subjects will be followed for ten years. Clinical and patient-reported outcome measures (PROMs) will be assessed.

Study Overview

• Status: Enrolling by invitation
• Conditions: Glenohumeral Osteoarthritis
• Intervention / Treatment: Device: Hemiarthroplasty with pyrocarbon; Device: Anatomic total shoulder arthroplasty

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Fluent in English language
2. Willing to sign an informed consent form
3. Willing to comply with all study procedures and be available for the duration of the study
4. Age 40 to 65 years
5. In good general health as evidenced by medical history
6. Surgical indication of glenohumeral osteoarthritis 7. In the opinion of the surgeon, there is clinical equipoise for the subject to be implanted with a humeral hemiarthroplasty with pyrocarbon or anatomic total shoulder arthroplasty

Exclusion Criteria:

1. Presence of Walch Type C or D glenoid
2. Presence of a glenoid that could not be reconstructed with the anatomic glenoid resurfacing components
3. Presence of extreme preoperative glenoid deformity including uniplanar retroversion deformity >30 o or severe biplanar deformity (retroversion >20 o and inclination > 10 o).
4. Workers' compensation case
5. Presence of full-thickness rotator cuff tear
6. Known allergic reactions to components of the study product(s)
7. History of consistent narcotic use within three months of surgery
8. History of chronic oral corticosteroid use
9. History or current drug or alcohol abuse
10. In the surgeon's opinion, the subject will be non-compliant with the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hemiarthroplasty with pyrocarbon	Device: Hemiarthroplasty with pyrocarbon; Hemiarthroplasty with pyrocarbon
Active Comparator: Anatomic total shoulder arthroplasty	Device: Anatomic total shoulder arthroplasty; Anatomic total shoulder arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single Assessment Numeric Evaluation score	Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain.	2-years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Visual Analog Pain Score	Assess pain relief. Range: 0-10. Zero is equivalent to no pain and 10 indicates the worst possible pain	2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Forgotten Joint score	Assess shoulder function. The total score ranges from 0 to 100 with higher scores indicating a high degree of forgetting the artificial joint.	2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Range of motion	Assess shoulder motion. Subjects will have their shoulder range of motion measured in degrees.	2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Assess rates of glenoid erosion	Assess rates of glenoid erosion associated with pyrocarbon hemiarthroplasty	2-years, 5-years, 10-years
Assess rates of aseptic glenoid loosening	Assess rates of aseptic glenoid loosening associated with anatomic total shoulder arthroplasty	2-years, 5-years, 10-years
Single Assessment Numeric Evaluation Score	Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain.	5-years, 10-years

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Benjamin Zmistowski, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): February 1, 2039
• Study Completion (Estimated): February 1, 2040

Study Registration Dates

• First Submitted: November 3, 2025
• First Submitted That Met QC Criteria: November 7, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: hemiarthroplasty; anatomic total shoulder arthroplasty; pyrocarbon
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Hemiarthroplasty
• Other Study ID Numbers: 202501233

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