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Custom Guides for Total Knee Arthroplasty (TKA)

Primary Purpose

Knee Osteoarthritis

Status
Active
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Custom guides
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for a TKA
  • Informed signed consent

Sites / Locations

  • CHUV - Site HO

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Register

Arm Description

Register

Outcomes

Primary Outcome Measures

Changes in mechanical axis of the lower limb
Mechanical axis of the lower limb as defined by the X-Ray evaluation form of the Knee Society Score
Changes in gait
Spatio temporal parameters of the gait

Secondary Outcome Measures

Full Information

First Posted
March 22, 2012
Last Updated
November 7, 2022
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT01573208
Brief Title
Custom Guides for Total Knee Arthroplasty (TKA)
Official Title
Prospective Cohort of FIRST TKA With Custom Guides
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Register
Arm Type
Experimental
Arm Description
Register
Intervention Type
Device
Intervention Name(s)
Custom guides
Intervention Description
Symbios custom guides for TKA
Primary Outcome Measure Information:
Title
Changes in mechanical axis of the lower limb
Description
Mechanical axis of the lower limb as defined by the X-Ray evaluation form of the Knee Society Score
Time Frame
Pre-operatively (up to 3 months);6months
Title
Changes in gait
Description
Spatio temporal parameters of the gait
Time Frame
Pre-operatively (up to 3 months); 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for a TKA Informed signed consent
Facility Information:
Facility Name
CHUV - Site HO
City
Lausanne
State/Province
CH
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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Custom Guides for Total Knee Arthroplasty (TKA)

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