Back to resultsComparison Between Fixed- Versus Mobile-bearing TKA
Primary Purpose
Knee Arthritis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
mobile-bearing TKA
fixed- bearing TKA
Sponsored by
About this trial
This is an interventional treatment trial for Knee Arthritis focused on measuring Mobile-bearing, arthroplasty, fixed-bearing, knee, patella, posterior stabilized TKA
Eligibility Criteria
Inclusion Criteria:
- Medial medial femorotibial arthritis requiring an arthroplasty
- Age between 50y and 90y
Exclusion Criteria:
- Lateral femorotibial arthritis
- Inflammatory disease
- Stiff knee with flexion under 90°
- Revision TKA
- Previous surgery (except meniscectomy)
Sites / Locations
- Sebastien Lustig
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mobile-bearing TKA
fixed- bearing TKA
Arm Description
Outcomes
Primary Outcome Measures
International Knee Society Score
Secondary Outcome Measures
Patellofemoral tilt on skyline view, measurement of two angles :
patellar tilt
patellar displacement from the center of the trochlear groove
Full Information
NCT ID
NCT00435357
First Posted
February 13, 2007
Last Updated
June 20, 2013
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT00435357
Brief Title
Comparison Between Fixed- Versus Mobile-bearing TKA
Official Title
Comparison Between Fixed- Versus Mobile-bearing TKA : a Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to analyse the clinical and radiological results of a postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial femorotibial arthritis will be included. The consequences on the patellofemoral joint will be thoroughly analysed on skyline view.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis
Keywords
Mobile-bearing, arthroplasty, fixed-bearing, knee, patella, posterior stabilized TKA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mobile-bearing TKA
Arm Type
Experimental
Arm Title
fixed- bearing TKA
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
mobile-bearing TKA
Intervention Type
Device
Intervention Name(s)
fixed- bearing TKA
Primary Outcome Measure Information:
Title
International Knee Society Score
Time Frame
2, 6 and 12 monthes after surgery
Secondary Outcome Measure Information:
Title
Patellofemoral tilt on skyline view, measurement of two angles :
Time Frame
2 and 12 monthes after surgery
Title
patellar tilt
Time Frame
2 and 12 monthes after surgery
Title
patellar displacement from the center of the trochlear groove
Time Frame
2 and 12 monthes after surgery
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:
Medial medial femorotibial arthritis requiring an arthroplasty
Age between 50y and 90y
Exclusion Criteria:
Lateral femorotibial arthritis
Inflammatory disease
Stiff knee with flexion under 90°
Revision TKA
Previous surgery (except meniscectomy)
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
Sebastien Lustig
City
Lyon
ZIP/Postal Code
69300
Country
France
12. IPD Sharing Statement
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Comparison Between Fixed- Versus Mobile-bearing TKA
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