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Custom Guides for Total Knee Arthroplasty (TKA)

This study is currently recruiting participants.
Verified April 2012 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: April 6, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
 Device: Custom guides
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Cohort of FIRST TKA With Custom Guides

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Register
Register
 Device: Custom guides
Symbios custom guides for TKA

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for a TKA
  • Informed signed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573208

Locations
Switzerland
CHUV - Site HO Recruiting
Lausanne, CH, Switzerland, 1011
Contact: B Jolles, MD MSc     +41 21 314 97 91        
Sponsors and Collaborators
University of Lausanne Hospitals
  More Information

No publications provided

Responsible Party: Brigitte Jolles, MD, Prof., University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01573208     History of Changes
Other Study ID Numbers: HO 278/10
Study First Received: March 22, 2012
Last Updated: April 6, 2012
Health Authority: Switzerland: Institutional Review Board

Keywords provided by University of Lausanne Hospitals:
Knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013