- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00132587
Total Knee Arthroplasty (TKA) Cemented Versus Cementless
Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69317
- Hôpital de la Croix-Rousse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
IKS (International Knee Society) score at 12 months
|
Secondary Outcome Measures
Outcome Measure |
---|
Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe Neyret, MD, Hospices Civils de Lyon
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003.313
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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