Discovery Elbow Long-Term Survivorship

Study Overview
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Brief Summary
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The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients.

Detailed Description
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Eligibility: Patient(s) must be enrolled in the Discovery Multi-Center Prospective Study. The patient must consent to participation in the Discovery Long-term Survivorship Study. In order to continue to follow the multi-center subjects long-term Biomet would like to extend the follow-up to include annual follow-ups from 10 to 15 years to document long-term survivorship. The annual follow-up will be obtained by sending annual questionnaire directly to the patients by mail. The Patient ASES questionnaire and survivorship data questions will be collected.

Official Title
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Discovery Elbow Long-Term Survivorship Study

Conditions
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Survivorship, Pain

Intervention / Treatment
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* Device: Discovery elbow minimally constrained


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant in the Discovery Elbow Multi-center Study Consent to participate in the Discovery Elbow Long-Term Survivorship Study Exclusion Criteria: Patient is not a Discovery Elbow Multi-center Participant Patient does not provide consent for the Discovery Elbow Long-term Survivorship Study
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: Discovery elbow minimally constrained|patient participating in the Discovery Elbow Multi-center study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Derived American Shoulder and Elbow Society (ASES) Pain Score | This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best) | 10 Years Post-op | 
| Patient Derived American Shoulder and Elbow Society (ASES) Function | This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function. | 10 Years Post-op | 
| Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction | This is the patient's perception of satisfaction with the elbow replacement surgery. Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction. | 10 Years Post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship Will be Measured by the Incidence of Revision or Removals | The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed | 10 years Post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elbow long-term Survivorship, Study participant Discovery Elbow Multi-center Study who, consent for the Discovery Elbow Long-term SurvivorshipStudy