Osteoarthritis of the ShoulderPYC CFSNCT05049993
Pyrocarbon Clinical Follow-up Study
An observational study of Osteoarthritis of the Shoulder and Avascular Necrosis, run by Stryker Trauma and Extremities at 8 sites in United States.
Trial summary
The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Osteoarthritis of the Shoulder, Avascular Necrosis, Traumatic Arthritis
- What is being tested?
- Aequalis Pyrocarbon Humeral Head
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 8 sitesUnited States
- Study dates
- 27 Oct 2021to 31 Dec 2027
- Phase
- Observational
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Long-term follow-up of Pyrocarbon IDE patients.
Who may be able to join
- Subject in the Pyrocarbon IDE Study and has not had the device explanted.
- Patient informed, willing, and able to sign an informed consent form approved by IRB or EC
- Willing and able to comply with the requirements of the study protocol
Who cannot join
- Subjects who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Missouri Orthopaedic Institute
Columbia, Missouri, 65211
HCA HealthONE, LLC
Denver, Colorado, 80218
Duke University
Durham, North Carolina, 27705
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Southern Oregon Orthopedics
Medford, Oregon, 97504
Allina Health Orthopedics
Minneapolis, Minnesota, 55407
Tulane University
New Orleans, Louisiana, 70112
Southern Maryland Orthopedics
Waldorf, Maryland, 20602
About this study
The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort.
Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).
- Being tested
- Aequalis Pyrocarbon Humeral Head
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aequalis Pyrocarbon Humeral HeadDevice
Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to last follow-up visit in ASES scores
ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
Measured: Follow-up visits through 10 years Post-Op
Secondary outcomes (7)
Change from Baseline to last follow-up visit in Constant Murley scores
Combination of physician-completed and patient-reported portions to assess functional state of shoulder including range of motion; total score reported out of 100 measuring where lower scores indicate less function of the evaluated shoulder
Measured: Follow-up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in SANE scores
SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%
Measured: Follow-up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in Subject Satisfaction scores
Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction
Measured: Follow-up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in EQ-5D scores
The EuroQol Five Dimensions Questionnaire (EQ-5D) questionnaire is a standardized instrument for use as a measure of quality of life. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for quality of life that can be used in the clinical and economic evaluation of health care. The EQ-5D consists of a descriptive system which comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), and a visual analog scale which measures the respondent's self-rated health on a 0-100 scale.
Measured: Follow-up visits through 10 years Post-Op
Number of device associated and procedure associated adverse events.
Measured: Follow-up visits through 10 years Post-Op
Evaluation of operated shoulder range of motion
Measured: Follow-up visits through 10 years Post-Op
Rates of revision surgeries.
Measured: Follow-up visits through 10 years Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start27 Oct 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma & Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049993
- Sponsor's protocol ID
- 20A-W-PYC-RM
- Acronym
- PYC CFS
- Status last verified
- Feb 2026
- First submitted
- 9 Sep 2021
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrocarbon Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT05049993
- Acronym / sponsor ID
- PYC CFS / 20A-W-PYC-RM
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Sep 2021 (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.
The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort.
Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Long-term follow-up of Pyrocarbon IDE patients.
Key inclusion criteria (3 listed)
- Subject in the Pyrocarbon IDE Study and has not had the device explanted.
- Patient informed, willing, and able to sign an informed consent form approved by IRB or EC
- Willing and able to comply with the requirements of the study protocol
Key exclusion criteria (1 listed)
- Subjects who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
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 |
|---|---|---|
| Aequalis Pyrocarbon Humeral HeadHemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head | Device | – |
Primary outcome
Change from Baseline to last follow-up visit in ASES scores
Time frame: Follow-up visits through 10 years Post-Op
ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
7 secondary outcomes
Change from Baseline to last follow-up visit in Constant Murley scores
Time frame: Follow-up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in SANE scores
Time frame: Follow-up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in Subject Satisfaction scores
Time frame: Follow-up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in EQ-5D scores
Time frame: Follow-up visits through 10 years Post-Op
Number of device associated and procedure associated adverse events.
Time frame: Follow-up visits through 10 years Post-Op
Evaluation of operated shoulder range of motion
Time frame: Follow-up visits through 10 years Post-Op
Rates of revision surgeries.
Time frame: Follow-up visits through 10 years Post-Op
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 1 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rebecca Gibson study director
Stryker Trauma & Extremities
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Shoulder and Avascular Necrosis, run by Stryker Trauma and Extremities at 8 sites 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Change from Baseline to last follow-up visit in ASES scores (time frame: Follow-up visits through 10 years Post-Op). 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 1 Sep 2026.