Comparison Between Fixed- Versus Mobile-bearing TKA

Knee Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435357
• Other study ID #: 2005.407
• Status: Completed
• Phase: N/A
• First received: February 13, 2007
• Last updated: June 20, 2013
• Start date: February 2007
• Est. completion date: July 2009

Study information

• Verified date: June 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthritis

Intervention

Device:
• mobile-bearing TKA

• fixed- bearing TKA

Locations

Country	Name	City	State
France	Sebastien Lustig	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Knee Society Score		2, 6 and 12 monthes after surgery	No
Secondary	Patellofemoral tilt on skyline view, measurement of two angles :		2 and 12 monthes after surgery	No
Secondary	patellar tilt		2 and 12 monthes after surgery	No
Secondary	patellar displacement from the center of the trochlear groove		2 and 12 monthes after surgery	No