Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07226388

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Glenohumeral Osteoarthritis

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fluent in English language
  • Willing to sign an informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Age 40 to 65 years
  • In good general health as evidenced by medical history
  • 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

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

Treatment and study plan

Hemiarthroplasty with pyrocarbon

Device

Hemiarthroplasty with pyrocarbon

Anatomic total shoulder arthroplasty

Device

Anatomic total shoulder arthroplasty

Primary outcomes

  1. Single Assessment Numeric Evaluation score

    Time frame: 2-years

    Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain.

Secondary outcomes

  1. American Shoulder and Elbow Visual Analog Pain Score

    Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years

    Assess pain relief. Range: 0-10. Zero is equivalent to no pain and 10 indicates the worst possible pain

  2. Forgotten Joint score

    Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years

    Assess shoulder function. The total score ranges from 0 to 100 with higher scores indicating a high degree of forgetting the artificial joint.

  3. Range of motion

    Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years

    Assess shoulder motion. Subjects will have their shoulder range of motion measured in degrees.

  4. Assess rates of glenoid erosion

    Time frame: 2-years, 5-years, 10-years

    Assess rates of glenoid erosion associated with pyrocarbon hemiarthroplasty

  5. Assess rates of aseptic glenoid loosening

    Time frame: 2-years, 5-years, 10-years

    Assess rates of aseptic glenoid loosening associated with anatomic total shoulder arthroplasty

  6. Single Assessment Numeric Evaluation Score

    Time frame: 5-years, 10-years

    Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2039
Study completion
2040
First posted
Nov 10, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.