ClinicalTrials.gg
Active, not recruitingNCT05049993PYC CFSUpdated Sep 1, 2026

Pyrocarbon Clinical Follow-up Study

An observational study in Osteoarthritis of the Shoulder, Avascular Necrosis and Traumatic Arthritis, sponsored by Stryker Trauma and Extremities. Active, not recruiting at 8 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Stryker Trauma and Extremities (part of Stryker) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
76
Ages
22 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 105 studies in Osteonecrosis with a site in United States — 17 open to participants now, 33 under way, 1 of them phase 3. Osteonecrosis · United States.

Enrollment
34th of 51
76 · median 131
Started
2021
with 2 others
Observational
51 of 105
9 open now
Primary completion
2027-05
later than 9 of 32 live
Registered
84th of 105
by date
Lead sponsor
4 of 105
Stryker Trauma and Extremities

Among the 105 studies in Osteonecrosis with a site in United States, this one is the 34th largest by enrollment of the 51 observational ones that give a count, is one of 3 that started in 2021, is one of 51 observational ones, reaches primary completion later than 9 of the 32 other live ones, and was the 84th registered.

Osteonecrosis

286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.

Browse Osteonecrosis studies →

Open to participants now

17 of the 105 studies in Osteonecrosis with a site in United States are open now. Recruiting first, the newest first:

12 more — sign in →

All 17 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 23 Osteonecrosis studies recruiting now, 14 (61%) set no upper age limit and 4 (17%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 22 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 105 studies in Osteonecrosis with a site in United States, or all of them as a file.
02

Study 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.

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).

03

Conditions studied

  • Osteoarthritis of the Shoulder
  • Avascular Necrosis
  • Traumatic Arthritis

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04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Long-term follow-up of Pyrocarbon IDE patients.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject in the Pyrocarbon IDE Study and has not had the device explanted.
  • Patient informed, willing, and able to sign an form approved by IRB or EC
  • Willing and able to comply with the requirements of the study protocol

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
76 participants (actual)
Patient registry
No

Interventions

  • DeviceAequalis Pyrocarbon Humeral Head

    Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Follow-up visits through 10 years Post-Op

Secondary outcomes

  1. 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

    Time frame: Follow-up visits through 10 years Post-Op

  2. 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%

    Time frame: Follow-up visits through 10 years Post-Op

  3. 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

    Time frame: Follow-up visits through 10 years Post-Op

  4. 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.

    Time frame: Follow-up visits through 10 years Post-Op

  5. Number of device associated and procedure associated adverse events.

    Time frame: Follow-up visits through 10 years Post-Op

  6. Evaluation of operated shoulder range of motion

    Time frame: Follow-up visits through 10 years Post-Op

  7. Rates of revision surgeries.

    Time frame: Follow-up visits through 10 years Post-Op

07

Study locations

8 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2021 (actual). Primary completion is estimated for May 2027, 67 months after the start.

Of 59 observational studies under Osteonecrosis, half reached primary completion within 141 months of starting (the median), counting those still running; a quarter within 93 and three quarters within 184. This study's planned 67 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2021
First posted
Sep 20, 2021
StartActual
Oct 27, 2021
Primary completionEst.
May 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05049993
Responsible party
Sponsor
First posted
Sep 20, 2021
Start date
Oct 27, 2021
Primary completion
May 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

Rebecca Gibson
study director · Stryker Trauma & Extremities

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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