Pyrocarbon Clinical Follow-up Study

N/AActive Not RecruitingNCT05049993

Stryker Trauma and Extremities76 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Osteoarthritis of the Shoulder Avascular Necrosis Traumatic Arthritis

Interventions

Aequalis Pyrocarbon Humeral HeadDEVICE

Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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)

Locations (8)

HCA HealthONE, LLC

Denver, Colorado, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Tulane University

New Orleans, Louisiana, United States

Southern Maryland Orthopedics

Waldorf, Maryland, United States

Outcomes

Primary Outcomes

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

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

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

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

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.

Data from ClinicalTrials.gov

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