Osteoarthritis, Knee
Conditions
Keywords
Knee arthroplasty, Femoral loosening, Total Knee Arthroplasty
Brief summary
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.
Interventions
DEVICEcement Palacos R40 and LV40
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Osteoarthritis (medial and/or lateral femoro-tibial arthritis and/or patellofemoral arthritis) * Indication of surgical treatment by total knee arthroplasty * Age between 50 and 90 years * Acceptance and signature to participate
Exclusion criteria
* Rheumatoid or other inflammatory arthritis * Association with other surgical procedure (osteotomy) * Range of motion inferior to 90° * Previous knee surgery (except arthroscopy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IKS (International Knee Society) score at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months | — |
Countries
France
Outcome results
None listed