LPS Flex Porous Femoral Components
|ClinicalTrials.gov Identifier: NCT01462240|
Recruitment Status : Active, not recruiting
First Posted : October 31, 2011
Last Update Posted : September 5, 2017
Information provided by (Responsible Party):
This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and long-term clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous Femoral components.
|Condition or disease||Intervention/treatment|
|Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Poly Arthritis Collagen Disorders Avascular Necrosis of Femoral Condyle||Device: LPS Flex Porous Femoral Components|
Survival and outcome data on the NexGen LPS-Flex Porous Femoral Components will be done by an analysis of standard scoring system, radiographs and adverse event records. Survivorship will be evaluated by monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated adverse device effects. Outcomes will be measured by comparing the overall pain and function performances (based on the Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters of study subjects receiving the LPS-Flex Porous Femoral Components.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Prospective Multicenter Post-market Study of the Zimmer NexGen LPS-Flex Porous Femoral Components|
|Actual Study Start Date :||May 20, 2008|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||December 2024|
1 - LPS Flex Pororus Femoral Components
Patients suffering from severe knee pain and disability.
Device: LPS Flex Porous Femoral Components
Porous femoral components in total knee arthroplasty
Primary Outcome Measures :
- Survivorship [ Time Frame: 10 Years ]Based on frequency of adverse events, serious adverse events, adverse device effects, serious adverse device effects and unanticipated adverse device effects or removal of the device summarized using a Kaplan-Meier method and presented with rates (as percentages) and confidence intervals.
Secondary Outcome Measures :
- Pain and Functional Performance [ Time Frame: 10 years ]Measured by comparing the overall pain and function performances (based on Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters.
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