Pyrocarbon Clinical Follow-up Study (PYC CFS)

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 Overview

• Status: Active, not recruiting
• Conditions: Avascular Necrosis; Traumatic Arthritis; Osteoarthritis of the Shoulder
• Intervention / Treatment: Device: Aequalis Pyrocarbon Humeral Head

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Western Orthopaedics
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • Maryland
    • Waldorf, Maryland, United States, 20602
      • Southern Maryland Orthopedics
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Allina Health Orthopedics
  • Missouri
    • Columbia, Missouri, United States, 65211
      • Missouri Orthopaedic Institute
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Oregon
    • Medford, Oregon, United States, 97504
      • Southern Oregon Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Long-term follow-up of Pyrocarbon IDE patients.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Follow-up visits through 10 years Post-Op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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%	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	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.	Follow-up visits through 10 years Post-Op
Number of device associated and procedure associated adverse events.		Follow-up visits through 10 years Post-Op
Evaluation of operated shoulder range of motion		Follow-up visits through 10 years Post-Op
Rates of revision surgeries.		Follow-up visits through 10 years Post-Op

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH
• Investigators: Study Director: Rebecca Gibson, Stryker Nordic

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: 20A-W-PYC-RM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No