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

NCT ID: NCT07226388

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2039-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glenohumeral Osteoarthritis

Keywords

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hemiarthroplasty anatomic total shoulder arthroplasty pyrocarbon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hemiarthroplasty with pyrocarbon

Group Type ACTIVE_COMPARATOR

Hemiarthroplasty with pyrocarbon

Intervention Type DEVICE

Hemiarthroplasty with pyrocarbon

Anatomic total shoulder arthroplasty

Group Type ACTIVE_COMPARATOR

Anatomic total shoulder arthroplasty

Intervention Type DEVICE

Anatomic total shoulder arthroplasty

Interventions

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Hemiarthroplasty with pyrocarbon

Hemiarthroplasty with pyrocarbon

Intervention Type DEVICE

Anatomic total shoulder arthroplasty

Anatomic total shoulder arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Zmistowski

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin Zmistowski, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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202501233

Identifier Type: -

Identifier Source: org_study_id