Comparison Between Fixed- Versus Mobile-Bearing TKA

This study is currently recruiting participants.

Verified by Hospices Civils de Lyon, April 2007

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00435357

Purpose

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.

Condition	Intervention
Knee Arthritis	Device: mobile-bearing TKA Device: fixed- bearing TKA

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Comparison Between Fixed- Versus Mobile-Bearing TKA : a Randomized Prospective Study

Further study details as provided by Hospices Civils de Lyon:

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

Estimated Enrollment:	128
Study Start Date:	February 2007

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435357

Contacts

Contact: Elvire Servien, MD

33 472 07 17 92

elvire.servien@chu-lyon.fr

Locations

France
Sebastien Lustig	Recruiting
Lyon, France, 69300
Contact: Sebastien Lustig, MD 33 472 07 19 73 sebastien.lustig@chu-lyon.fr

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Philippe Neyret, MD

Hospices Civils de Lyon

More Information

No publications provided

Study ID Numbers:	2005.407
Study First Received:	February 13, 2007
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00435357
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Mobile-bearing
arthroplasty
fixed-bearing

knee
patella
posterior stabilized TKA

Study placed in the following topic categories:

Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on February 12, 2009