Custom Guides for Total Knee Arthroplasty (TKA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Lausanne Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Brigitte Jolles, MD, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01573208
First received: March 22, 2012
Last updated: April 6, 2012
Last verified: April 2012

March 22, 2012
April 6, 2012
February 2011
June 2012   (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
Not Provided
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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.

Not Provided
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
Not Provided
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for a TKA
  • Informed signed consent
Both
Not Provided
No
Switzerland
 
NCT01573208
HO 278/10
Not Provided
Brigitte Jolles, MD, University of Lausanne Hospitals
University of Lausanne Hospitals
Not Provided
Not Provided
University of Lausanne Hospitals
April 2012

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