Custom Guides for Total Knee Arthroplasty (TKA)

Phase 4

Active, not recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Device: Custom guides

• Registration Number: NCT01573208
• Lead Sponsor: University of Lausanne Hospitals

Brief Summary

The goal of the study is to know if the reconstruction of the lower limb mechanical axis and the patient knee function is improved after Total Knee Arthroplasty (TKA) using patient specific instruments.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-04-06
• Study First Posted: 2012-04-09
• Primary Completion: 2013-11
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients scheduled for a TKA
• Informed signed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Register	Custom guides	Register

Primary Outcome Measures

Name	Time	Method
Changes in mechanical axis of the lower limb	Pre-operatively (up to 3 months);6months	Mechanical axis of the lower limb as defined by the X-Ray evaluation form of the Knee Society Score
Changes in gait	Pre-operatively (up to 3 months); 6 months	Spatio temporal parameters of the gait

Trial Locations

Locations (1)

CHUV - Site HO; 🇨🇭 Lausanne, CH, Switzerland