Discovery Elbow Long-Term Survivorship Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Zimmer Biomet
- Enrollment
- 29
- Locations
- 4
- Primary Endpoint
- Patient Derived American Shoulder and Elbow Society (ASES) Pain Score
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Patient Derived American Shoulder and Elbow Society (ASES) Pain Score
Time Frame: 10 Years Post-op
This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)
Patient Derived American Shoulder and Elbow Society (ASES) Function
Time Frame: 10 Years Post-op
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.
Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction
Time Frame: 10 Years Post-op
This is the patient's perception of satisfaction with the elbow replacement surgery. Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction.
Secondary Outcomes
- Survivorship Will be Measured by the Incidence of Revision or Removals(10 years Post-op)