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)|
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
|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|