Discovery Elbow Long-Term Survivorship
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||September 2016|
|Study Completion Date :||September 2016|
Device: Discovery elbow minimally constrained
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|