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NCT01573208 Clinical Trial

Custom Guides for Total Knee Arthroplasty (TKA)

Knee Osteoarthritis Clinical Trial

Official title:
Prospective Cohort of FIRST TKA With Custom Guides

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01573208
Other study ID # HO 278/10
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date February 2011
Est. completion date December 2022

Study information
Verified date November 2022
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 80
Est. completion date December 2022
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients scheduled for a TKA - Informed signed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Custom guides
Symbios custom guides for TKA

Locations
Country Name City State
Switzerland CHUV - Site HO Lausanne CH

Sponsors (1)
Lead Sponsor Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in mechanical axis of the lower limb Mechanical axis of the lower limb as defined by the X-Ray evaluation form of the Knee Society Score Pre-operatively (up to 3 months);6months
Primary Changes in gait Spatio temporal parameters of the gait Pre-operatively (up to 3 months); 6 months
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