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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 7, 2007 | ||||
| Last Updated Date | August 5, 2009 | ||||
| Start Date ICMJE | May 2007 | ||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Patient examination measurements and radiographic measurements will be used to determine the effects of the Discovery Elbow implant [ Time Frame: Pre-operative to Five year post-operative appointment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Patient examination measurements and radiographic measurements will be used to determine the effects of the Discovery Elbow implant [ Time Frame: Pre-operative to Five year post-operative appointment ] | ||||
| Change History | Complete list of historical versions of study NCT00515515 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Discovery Elbow Multi-Center Prospective Study | ||||
| Official Title ICMJE | Discovery Elbow Multi-Center Prospective Study | ||||
| Brief Summary | The purpose of this prospective clinical trial is to document the performance and clinical outcomes of Biomet Discovery Elbow. |
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| Detailed Description | About 3 years ago, Biomet engineers began developing a completely different elbow system. They focused on problems of past elbow designs, including:
Discovery™ design goals:
The rationale behind the Discovery™ Elbow was to create a device that closely matches the anatomy, while providing a superior hinge mechanism that is easier to assemble and revise should it become necessary. It was also a priority to create an instrument set that was ideal for a broad range of surgeons. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment | ||||
| Condition ICMJE | Elbow Replacement | ||||
| Intervention ICMJE | Device: Discovery Elbow replacement | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | May 2010 | ||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Patient Selection Factors to be considered include:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00515515 | ||||
| Responsible Party | Dr. Donald Lee, Vanderbilt University | ||||
| Study ID Numbers ICMJE | 060092 | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | Biomet, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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