NCT07226388

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
167mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Feb 2026Feb 2040

First Submitted

Initial submission to the registry

November 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 3, 2026

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2039

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2040

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

13 years

First QC Date

November 3, 2025

Last Update Submit

February 17, 2026

Conditions

Glenohumeral Osteoarthritis

Keywords

hemiarthroplastyanatomic total shoulder arthroplastypyrocarbon

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • American Shoulder and Elbow Visual Analog Pain Score

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

  • Forgotten Joint score

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

  • Range of motion

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

  • Assess rates of glenoid erosion

    2-years, 5-years, 10-years

  • Assess rates of aseptic glenoid loosening

    2-years, 5-years, 10-years

  • +1 more secondary outcomes

Study Arms (2)

Hemiarthroplasty with pyrocarbon

ACTIVE COMPARATOR
Device: Hemiarthroplasty with pyrocarbon

Anatomic total shoulder arthroplasty

ACTIVE COMPARATOR
Device: Anatomic total shoulder arthroplasty

Interventions

Hemiarthroplasty with pyrocarbonDEVICE

Hemiarthroplasty with pyrocarbon

Hemiarthroplasty with pyrocarbon
Anatomic total shoulder arthroplastyDEVICE

Anatomic total shoulder arthroplasty

Anatomic total shoulder arthroplasty

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

Hemiarthroplasty

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Benjamin Zmistowski, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 3, 2025

First Posted

November 10, 2025

Study Start

February 3, 2026

Primary Completion (Estimated)

February 1, 2039

Study Completion (Estimated)

February 1, 2040

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

US(1)