Glenohumeral OsteoarthritisNCT07226388
Pyrocarbon Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis
A study testing Hemiarthroplasty with pyrocarbon and Anatomic total shoulder arthroplasty in people with Glenohumeral Osteoarthritis, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Glenohumeral Osteoarthritis
- What is being tested?
- Hemiarthroplasty with pyrocarbon and Anatomic total shoulder arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2026to Feb 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis: The Impact of Modern Implant Options
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.
- Conditions
- Glenohumeral Osteoarthritis
- Being tested
- Hemiarthroplasty with pyrocarbon, Anatomic total shoulder arthroplasty
- Keywords
- hemiarthroplasty, anatomic total shoulder arthroplasty, pyrocarbon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemiarthroplasty with pyrocarbonDevice
Hemiarthroplasty with pyrocarbon
Anatomic total shoulder arthroplastyDevice
Anatomic total shoulder arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Hemiarthroplasty with pyrocarbon | Active comparator | Not described Receives: Device: Hemiarthroplasty with pyrocarbon |
| Anatomic total shoulder arthroplasty | Active comparator | Not described Receives: Device: Anatomic total shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-years
Secondary outcomes (6)
American Shoulder and Elbow Visual Analog Pain Score
Assess pain relief. Range: 0-10. Zero is equivalent to no pain and 10 indicates the worst possible pain
Measured: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Forgotten Joint score
Assess shoulder function. The total score ranges from 0 to 100 with higher scores indicating a high degree of forgetting the artificial joint.
Measured: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Range of motion
Assess shoulder motion. Subjects will have their shoulder range of motion measured in degrees.
Measured: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Assess rates of glenoid erosion
Assess rates of glenoid erosion associated with pyrocarbon hemiarthroplasty
Measured: 2-years, 5-years, 10-years
Assess rates of aseptic glenoid loosening
Assess rates of aseptic glenoid loosening associated with anatomic total shoulder arthroplasty
Measured: 2-years, 5-years, 10-years
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.
Measured: 5-years, 10-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start3 Feb 2026
- Primary completionFeb 2039 (estimated)
- Study completionFeb 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Zmistowski, Washington University School of Medicine
- Investigators
- Benjamin Zmistowski, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226388
- Sponsor's protocol ID
- 202501233
- Status last verified
- Feb 2026
- First submitted
- 3 Nov 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis: The Impact of Modern Implant Options
- ClinicalTrials.gov ID
- NCT07226388
- Acronym / sponsor ID
- 202501233
- Conditions
- Glenohumeral Osteoarthritis
- Keywords
- hemiarthroplasty, anatomic total shoulder arthroplasty, pyrocarbon
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- Feb 2039 (estimated)
- Study completion
- Feb 2040 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemiarthroplasty with pyrocarbon | Active comparator | Device: Hemiarthroplasty with pyrocarbon |
| Anatomic total shoulder arthroplasty | Active comparator | Device: Anatomic total shoulder arthroplasty |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemiarthroplasty with pyrocarbonHemiarthroplasty with pyrocarbon | Device | Hemiarthroplasty with pyrocarbon |
| Anatomic total shoulder arthroplastyAnatomic total shoulder arthroplasty | Device | Anatomic total shoulder arthroplasty |
Primary outcome
Single Assessment Numeric Evaluation score
Time frame: 2-years
Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain.
6 secondary outcomes
American Shoulder and Elbow Visual Analog Pain Score
Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Forgotten Joint score
Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Range of motion
Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Assess rates of glenoid erosion
Time frame: 2-years, 5-years, 10-years
Assess rates of aseptic glenoid loosening
Time frame: 2-years, 5-years, 10-years
Single Assessment Numeric Evaluation Score
Time frame: 5-years, 10-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Zmistowski, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemiarthroplasty with pyrocarbon and Anatomic total shoulder arthroplasty in people with Glenohumeral Osteoarthritis, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Assessment Numeric Evaluation score (time frame: 2-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.