NCT01573208

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 9, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
9.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

2.8 years

First QC Date

March 22, 2012

Last Update Submit

November 7, 2022

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • 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

    Pre-operatively (up to 3 months);6months

  • Changes in gait

    Spatio temporal parameters of the gait

    Pre-operatively (up to 3 months); 6 months

Study Arms (1)

Register

EXPERIMENTAL

Register

Device: Custom guides

Interventions

Custom guidesDEVICE

Symbios custom guides for TKA

Register

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for a TKA
  • Informed signed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV - Site HO

Lausanne, CH, 1011, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 22, 2012

First Posted

April 9, 2012

Study Start

February 1, 2011

Primary Completion

November 1, 2013

Study Completion

December 1, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations

CH(1)