TKA Cemented Versus Cementless - Article Degenerative Joint Disease; Osteoarthritis arthritis
Clinical Trial: TKA Cemented Versus Cementless
This study is currently recruiting patients.
Verified by Hospices Civils de Lyon July 2005
The aim of the study is to analyse and to compare the quality of fixation of femoral implant with or without cement.
130 patients will be operate and include with 2 groups, the first with TKA all cemented and the second one with TKA with cementless femoral implant The study criteria is the IKS (international knee society) score and the analyse of a radiolucent line at the femur.
Patients will be review at 2, 6 and 12 months.
|Knee Osteoarthritis || Device: cement Palacos R40 and LV40 |
MedlinePlus related topics: 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
Secondary Outcomes: Analysis of femoral radiolucent line at the X-rays (profile and AP view) at 12 months
Expected Total Enrollment: 130
Study start: March 2004
- osteoarthritis (medial or/and lateral femoro-tibial arthritis or/and patello-femoral arthritis)
- indication of surgical treatment by Total Knee Arthroplasty
- age between 50 and 90 ys
- acceptation and signature to participate
Location and Contact Information
Elvire SERVIEN, Lyon, 69300, France; Recruiting
Philippe NEYRET, MD, Principal Investigator
Philippe NEYRET, MD, Principal Investigator, Hospices Civils de Lyon
Last Updated: August 19, 2005
Record first received: August 19, 2005
ClinicalTrials.gov Identifier: NCT00132587
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23