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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT01661647

Collaborator

Eiffel Medtech (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
3D Knee Kinematics	Device: 3D knee kinematic assessment under local anesthesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 2, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

3D knee kinematics [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.

Secondary Outcome Measures

Correlation of kinematic data with clinical laxity tests [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHUM	Montréal	Quebec	Canada	H2X 3E4

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)
Eiffel Medtech

Investigators

Principal Investigator: Frédéric Lavoie, MD MSc FRCSC, CHUM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre hospitalier de l'Université de Montréal (CHUM)

ClinicalTrials.gov Identifier:

NCT01661647

Other Study ID Numbers:

CE 12.005

First Posted:

Aug 9, 2012

Last Update Posted:

Aug 23, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Aug 23, 2021