Pyrocarbon Clinical Follow-up Study

Avascular Necrosis Clinical Trial

— PYC CFS  

Official title:

Pyrocarbon Clinical Follow-up Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05049993
• Other study ID #: 20A-W-PYC-RM
• Status: Active, not recruiting
• Start date: October 27, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Stryker Trauma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: December 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Avascular Necrosis
• Necrosis
• Osteoarthritis of the Shoulder
• Traumatic Arthritis

Intervention

Device:
• Aequalis Pyrocarbon Humeral Head
Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head

Locations

Country	Name	City	State
United States	Missouri Orthopaedic Institute	Columbia	Missouri
United States	Western Orthopaedics	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Southern Oregon Orthopedics	Medford	Oregon
United States	Allina Health Orthopedics	Minneapolis	Minnesota
United States	Tulane University	New Orleans	Louisiana
United States	Southern Maryland Orthopedics	Waldorf	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of device associated and procedure associated adverse events.		Follow-up visits through 10 years Post-Op
Secondary	Evaluation of operated shoulder range of motion		Follow-up visits through 10 years Post-Op
Secondary	Rates of revision surgeries.		Follow-up visits through 10 years Post-Op