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

Conditions

• Glenohumeral Osteoarthritis

Eligibility Criteria

Sex

ALL

Age

40 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Hemiarthroplasty with pyrocarbon — DEVICE
  Hemiarthroplasty with pyrocarbon
• Anatomic total shoulder arthroplasty — DEVICE
  Anatomic total shoulder arthroplasty

Study Details

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.

Key Dates

Start date

Feb 3, 2026

Status verified

Feb 2026

Primary completion

Feb 28, 2039

Completion

Feb 29, 2040

Study Design

Enrollment

74 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Hemiarthroplasty with pyrocarbon
• Active Comparator: Anatomic total shoulder arthroplasty

Primary Outcome Measure

Single Assessment Numeric Evaluation score [ Time Frame: 2-years ]

Locations (1)

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