Pyrocarbon Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral … (NCT07226388) | Clinical Trial Compass
By InvitationNot Applicable
Pyrocarbon Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis
United States74 participantsStarted 2026-02-03
Plain-language 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.
Who can participate
Age range
40 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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