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NCT Number: NCT05049993

Pyrocarbon Clinical Follow-up 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis of the Shoulder Avascular Necrosis Bone Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Traumatic Arthritis

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HCA HealthONE, LLC, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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)

Treatment and study plan

Aequalis Pyrocarbon Humeral Head

Device

Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from Baseline to last follow-up visit in Constant Murley scores

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

    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

  2. Change from Baseline to last follow-up visit in SANE scores

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

    SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%

  3. Change from Baseline to last follow-up visit in Subject Satisfaction scores

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

    Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction

  4. Change from Baseline to last follow-up visit in EQ-5D scores

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

    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.

  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

Sponsors and collaborators

Lead sponsor

Stryker Trauma and Extremities

Industry

Registry information

Acronym: PYC CFS

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Sep 20, 2021
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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