Pyrocarbon Clinical Follow-up Study

Study Overview
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Brief Summary
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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).

Official Title
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Pyrocarbon Clinical Follow-up Study

Conditions
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Osteoarthritis of the Shoulder, Avascular Necrosis, Traumatic Arthritis

Intervention / Treatment
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* Device: Aequalis Pyrocarbon Humeral Head


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Aequalis Pyrocarbon Humeral Head|Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head|

What is the study measuring?
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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 |