Discovery Elbow Long-Term Survivorship
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Discovery Elbow Long-Term Survivorship Study|
- 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.
- Survivorship Will be Measured by the Incidence of Revision or Removals [ Time Frame: 10 years Post-op ]The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed
|Study Start Date:||January 2011|
|Study Completion Date:||September 2016|
|Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Device: Discovery elbow minimally constrained
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308463
|United States, Florida|
|Florida Orthopedic Institute|
|Tampa, Florida, United States, 33637|
|United States, Indiana|
|The Indiana Hand to Shoulder Center|
|Indianapolis, Indiana, United States, 46260|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Tennessee|
|Vanderbilt Hand Center|
|Nashville, Tennessee, United States, 37232|
|Study Director:||Russell Schenck, PhD||Director Clinical Research, Biomet Orthopedics, LLC|