Custom Guides for Total Knee Arthroplasty (TKA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
Brigitte Jolles, MD, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01573208
First received: March 22, 2012
Last updated: May 17, 2016
Last verified: May 2016

March 22, 2012
May 17, 2016
February 2011
September 2017   (final data collection date for primary outcome measure)
  • Changes in mechanical axis of the lower limb [ Time Frame: Pre-operatively (up to 3 months);6months ] [ Designated as safety issue: No ]
    Mechanical axis of the lower limb as defined by the X-Ray evaluation form of the Knee Society Score
  • Changes in gait [ Time Frame: Pre-operatively (up to 3 months); 6 months ] [ Designated as safety issue: No ]
    Spatio temporal parameters of the gait
Same as current
Complete list of historical versions of study NCT01573208 on ClinicalTrials.gov Archive Site
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Custom Guides for Total Knee Arthroplasty (TKA)
Prospective Cohort of FIRST TKA With Custom Guides
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.
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Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Knee Osteoarthritis
Device: Custom guides
Symbios custom guides for TKA
Experimental: Register
Register
Intervention: Device: Custom guides
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
October 2017
September 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for a TKA
  • Informed signed consent
Both
Child, Adult, Senior
No
Switzerland
 
NCT01573208
HO 278/10
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Brigitte Jolles, MD, University of Lausanne Hospitals
University of Lausanne Hospitals
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Not Provided
University of Lausanne Hospitals
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP