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

NCT01661647 | Not Yet Recruiting DMC

• 1 other identifier: CE 12.005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

3D Knee Kinematics

Outcome Measures

Primary Outcomes (1)

• 3D knee kinematics

  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 Outcomes (1)

• Correlation of kinematic data with clinical laxity tests

  On the day of surgery, before knee arthroscopy

Study Arms (1)

3D knee kinematic assessment

EXPERIMENTAL

3D knee kinematic assessment under local anesthesia

Device: 3D knee kinematic assessment under local anesthesia

Interventions

3D knee kinematic assessment under local anesthesia DEVICE

3D knee kinematic assessment under local anesthesia

3D knee kinematic assessment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Eiffel Medtech: collaborator

Study Sites (1)

CHUM

Montreal, Quebec, H2X 3E4, Canada

Location

Study Officials

• Frédéric Lavoie, MD MSc FRCSC

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Lavoie, MD MSc FRCSC

CONTACT

1-514-890-8000; fredericlavoiemd@gmail.com

Fidaa Al-Shakfa, MSc

CONTACT

1-514-890-8000; f.alshakfa.crchum@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: August 9, 2012
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

CA (1)