Back to resultsTotal Knee Arthroplasty (TKA) Cemented Versus Cementless
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cement Palacos R40 and LV40
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee arthroplasty, Femoral loosening, Total Knee Arthroplasty
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)
Sites / Locations
- Hôpital de la Croix-Rousse
Outcomes
Primary Outcome Measures
IKS (International Knee Society) score at 12 months
Secondary Outcome Measures
Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00132587
Brief Title
Total Knee Arthroplasty (TKA) Cemented Versus Cementless
Official Title
Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Knee arthroplasty, Femoral loosening, Total Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
130 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
cement Palacos R40 and LV40
Primary Outcome Measure Information:
Title
IKS (International Knee Society) score at 12 months
Secondary Outcome Measure Information:
Title
Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe NEYRET, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
20194310
Citation
Demey G, Servien E, Pinaroli A, Lustig S, Ait Si Selmi T, Neyret P. The influence of femoral cementing on perioperative blood loss in total knee arthroplasty: a prospective randomized study. J Bone Joint Surg Am. 2010 Mar;92(3):536-41. doi: 10.2106/JBJS.H.01159.
Results Reference
result
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Total Knee Arthroplasty (TKA) Cemented Versus Cementless
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