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| Sponsored by: |
Hospices Civils de Lyon |
| Information provided by: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT00132587 |
Purpose
The aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement.
One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. The study criteria include the IKS (International Knee Society) score and the analysis of a radiolucent line at the femur.
Patients will be reviewed at 2, 6 and 12 months.
| Condition | Intervention |
|
Osteoarthritis, Knee |
Device: cement Palacos R40 and LV40 |
| MedlinePlus related topics: | Knee Replacement Osteoarthritis |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment |
| Official Title: | Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless |
| Estimated Enrollment: | 130 |
| Study Start Date: | March 2004 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Hospices Civils de Lyon ( Philippe Neyret ) |
| Study ID Numbers: | 2003.313 |
| First Received: | August 19, 2005 |
| Last Updated: | June 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00132587 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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