3D Kinematic Assessment of the Human Knee During Physical and Daily Life Activities

July 31, 2023 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

(Étude de la cinématique Tridimensionnelle du Genou Humain Lors de Gestes Sportifs et de la Vie Courante)

Problem : Precise and personalized 3D knee kinematic assessment during physical and daily life activities is a challenge; therefore, it was never performed on an important number of individuals. However, a better understanding of 3D knee kinematics during such activities would allow a better understanding of this often injured joint.

Hypothesis: A new system using personalized 3D bone imaging and a percutaneous bone fixation device that can be used under local anesthesiaallows for precise and reproducible assessment of 3D knee kinematics during physical and daily life activities.

Objectives :

  • To study human knee 3D kinematics during dynamic activities using a novel minimally invasive measuring system
  • Investigate the correlations between standard clinical knee laxity tests and measured 3D knee kinematics during dynamic activities

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 3E4
        • CHUM
        • Contact:
          • Frédéric Lavoie, MD MSc FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients awaiting knee arthroscopy under local anesthesia for a medial meniscal tear

Exclusion Criteria:

  • Active infection
  • Severe swelling of the knee
  • Knee flexion contracture
  • Knee flexion less than 120 degrees
  • Gross limping
  • Inability to perform the various motor tasks required by the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D knee kinematic assessment
3D knee kinematic assessment under local anesthesia
Device: 3D knee kinematic assessment under local anesthesia
3D knee kinematic assessment under local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D knee kinematics
Time Frame: On the day of the surgery, before knee arthroscopy
The investigators will investigate if 3D knee kinematics can be precisely and safely measured under local anesthesia during various motor tasks (walking, squatting, pivoting, jumping): kinematic data will be analyzed in search of signs of artefact movement and kinematic aberrations, which would indicate problems with the measurement system.
On the day of the surgery, before knee arthroscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of kinematic data with clinical laxity tests
Time Frame: On the day of surgery, before knee arthroscopy
With the kinematic measurement device attached to the bones of the lower limbs, various knee laxity tests will be performed by a physician while the kinematics of the knee are recorded; correlations will be sought between the subjective evaluation of the physician and the kinematic data.
On the day of surgery, before knee arthroscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Eiffel Medtech

Investigators

  • Principal Investigator: Frédéric Lavoie, MD MSc FRCSC, CHUM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 2, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimated)

August 9, 2012

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 12.005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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