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Custom Guides for Total Knee Arthroplasty (TKA)

This study is currently recruiting participants.
Verified November 2017 by Brigitte Jolles, MD, University of Lausanne Hospitals
Sponsor:
ClinicalTrials.gov Identifier:
NCT01573208
First Posted: April 9, 2012
Last Update Posted: November 7, 2017
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.
Information provided by (Responsible Party):
Brigitte Jolles, MD, University of Lausanne Hospitals
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Cohort of FIRST TKA With Custom Guides

Resource links provided by NLM:


Further study details as provided by Brigitte Jolles, MD, University of Lausanne Hospitals:

Primary Outcome Measures:
  • 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

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


Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Register
Register
Device: Custom guides
Symbios custom guides for TKA

  Eligibility

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
Criteria

Inclusion Criteria:

  • Patients scheduled for a TKA
  • Informed signed consent
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Brigitte Jolles, MD, Prof., University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01573208     History of Changes
Other Study ID Numbers: HO 278/10
First Submitted: March 22, 2012
First Posted: April 9, 2012
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
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases