Pyrocarbon Clinical Follow-up Study

Active, not recruiting

• Conditions: Osteoarthritis of the Shoulder; Traumatic Arthritis; Avascular Necrosis

• Registration Number: NCT05049993
• Lead Sponsor: Stryker Trauma and Extremities

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-20
• Study Start: 2021-10-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Primary Completion: 2027-05-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline to last follow-up visit in ASES scores	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 Outcome Measures

Name	Time	Method
Change from Baseline to last follow-up visit in Constant Murley scores	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
Change from Baseline to last follow-up visit in EQ-5D scores	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.
Number of device associated and procedure associated adverse events.	Follow-up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in SANE scores	Follow-up visits through 10 years Post-Op	SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%
Change from Baseline to last follow-up visit in Subject Satisfaction scores	Follow-up visits through 10 years Post-Op	Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction
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

Trial Locations

Locations (8)

Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

Western Orthopaedics; 🇺🇸 Denver, Colorado, United States

Southern Maryland Orthopedics; 🇺🇸 Waldorf, Maryland, United States

Southern Oregon Orthopedics; 🇺🇸 Medford, Oregon, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Allina Health Orthopedics; 🇺🇸 Minneapolis, Minnesota, United States

Missouri Orthopaedic Institute; 🇺🇸 Columbia, Missouri, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States