Comparison Between Fixed- Versus Mobile-bearing TKA

June 20, 2013 updated by: Hospices Civils de Lyon

Comparison Between Fixed- Versus Mobile-bearing TKA : a Randomized Prospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69300
        • Sebastien Lustig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mobile-bearing TKA
Device: mobile-bearing TKA
Active Comparator: fixed- bearing TKA
Device: fixed- bearing TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
International Knee Society Score
Time Frame: 2, 6 and 12 monthes after surgery
2, 6 and 12 monthes after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Patellofemoral tilt on skyline view, measurement of two angles :
Time Frame: 2 and 12 monthes after surgery
2 and 12 monthes after surgery
patellar tilt
Time Frame: 2 and 12 monthes after surgery
2 and 12 monthes after surgery
patellar displacement from the center of the trochlear groove
Time Frame: 2 and 12 monthes after surgery
2 and 12 monthes after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Philippe Neyret, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 13, 2007

First Submitted That Met QC Criteria

February 13, 2007

First Posted (Estimate)

February 14, 2007

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005.407

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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