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

The Washington University

Status: Invitation-only

Conditions: Glenohumeral Osteoarthritis

Treatments: Device: Anatomic total shoulder arthroplasty; Device: Hemiarthroplasty with pyrocarbon

Study type: Interventional

Funder types: Other

Identifiers

NCT07226388

202501233

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Hemiarthroplasty with pyrocarbon

Active Comparator group

Treatment:

Device: Hemiarthroplasty with pyrocarbon

Anatomic total shoulder arthroplasty

Active Comparator group

Treatment:

Device: Anatomic total shoulder arthroplasty