Discovery Elbow Long-Term Survivorship
|ClinicalTrials.gov Identifier: NCT01308463|
Recruitment Status : Terminated (Study terminated due to change in sponsorship)
First Posted : March 4, 2011
Results First Posted : May 1, 2017
Last Update Posted : May 1, 2017
|Condition or disease||Intervention/treatment|
|Survivorship Pain||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.
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||Discovery Elbow Long-Term Survivorship Study|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
- Device: Discovery elbow minimally constrained
patient participating in the Discovery Elbow Multi-center 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|