Discovery Elbow Long-Term Survivorship
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Discovery Elbow Long-Term Survivorship Study|
- Patient ASES Assessment [ Time Frame: 10 years - 15 years ] [ Designated as safety issue: No ]This patient questionnaire asks questions related to pain, range of motion, work and sports activity.
- Survivorship will be measured by the incidence of revision or removals [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]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|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Discovery Minimally constrained elbow
Device: Discovery elbow minimally constrained
patient participating in the Discovery Elbow Multi-center study
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.
|Contact: Russell Schenck, PhDfirstname.lastname@example.org|
|Contact: Carol Lauster||(574) email@example.com|
|United States, Florida|
|Florida Orthopedic Institute||Recruiting|
|Tampa, Florida, United States, 33637|
|United States, Indiana|
|The Indiana Hand to Shoulder Center||Active, not recruiting|
|Indianapolis, Indiana, United States, 46260|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|United States, Tennessee|
|Vanderbilt Hand Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Study Director:||Russell Schenck, PhD||Director Clinical Research, Biomet Orthopedics, LLC|