Custom Guides for Total Knee Arthroplasty (TKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01573208
Recruitment Status : Recruiting
First Posted : April 9, 2012
Last Update Posted : November 7, 2017
Information provided by (Responsible Party):
Brigitte Jolles, MD, 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Custom guides Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Cohort of FIRST TKA With Custom Guides
Study Start Date : February 2011
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Register
Device: Custom guides
Symbios custom guides for TKA

Primary Outcome Measures :
  1. Changes in mechanical axis of the lower limb [ Time Frame: 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

  2. Changes in gait [ Time Frame: Pre-operatively (up to 3 months); 6 months ]
    Spatio temporal parameters of the gait

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled for a TKA
  • Informed signed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01573208

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

Responsible Party: Brigitte Jolles, MD, Prof., University of Lausanne Hospitals Identifier: NCT01573208     History of Changes
Other Study ID Numbers: HO 278/10
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by Brigitte Jolles, MD, University of Lausanne Hospitals:
Knee osteoarthritis

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