NCT00132587
Completed
Not Applicable
Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless
ConditionsOsteoarthritis, Knee
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- IKS (International Knee Society) score at 12 months
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
IKS (International Knee Society) score at 12 months
Secondary Outcomes
- Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months
Study Sites (1)
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