Custom Guides for Total Knee Arthroplasty (TKA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University of Lausanne Hospitals
Information provided by (Responsible Party):
Brigitte Jolles, MD, University of Lausanne Hospitals Identifier:
First received: March 22, 2012
Last updated: June 3, 2015
Last verified: June 2015
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:

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 Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Register
Device: Custom guides
Symbios custom guides for TKA


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled for a TKA
  • Informed signed consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Brigitte Jolles, MD, Prof., University of Lausanne Hospitals Identifier: NCT01573208     History of Changes
Other Study ID Numbers: HO 278/10
Study First Received: March 22, 2012
Last Updated: June 3, 2015
Health Authority: Switzerland: Institutional Review Board

Keywords provided by University of Lausanne Hospitals:
Knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on December 01, 2015