Foundation Knee Study - Retrospective
This study has been terminated.
(Enrollment and data collection insufficient to continue study.)
Sponsor:
Encore Medical, L.P.
Information provided by:
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00764894
First received: September 30, 2008
Last updated: February 8, 2011
Last verified: February 2011
| Tracking Information | |||||
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| First Received Date ICMJE | September 30, 2008 | ||||
| Last Updated Date | February 8, 2011 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The use and efficacy of the Encore Foundation Knee System [ Time Frame: 2 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00764894 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Foundation Knee Study - Retrospective | ||||
| Official Title ICMJE | Post-Market Study of the Foundation Knee System | ||||
| Brief Summary | The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Individuals who meet the indications for use of the Foundation Knee device AND who meet the inclusion/exclusion criteria |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Foundation Knee
Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis who received a primary Foundation Knee replacement and is willing to participate in the study. |
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| Study Group/Cohort (s) | Foundation Knee
Retrospective data collection on 510(k) approved device
Intervention: Device: Foundation Knee |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | February 2011 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00764894 | ||||
| Other Study ID Numbers ICMJE | PS - 701 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jane M. Jacob Ph.D., DJO Surgical | ||||
| Study Sponsor ICMJE | Encore Medical, L.P. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Encore Medical, L.P. | ||||
| Verification Date | February 2011 | ||||
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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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