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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01661647
Other study ID # CE 12.005
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2, 2024
Est. completion date December 1, 2025

Study information

Verified date July 2023
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact Frédéric Lavoie, MD MSc FRCSC
Phone 1-514-890-8000
Email fredericlavoiemd@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date December 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
3D knee kinematic assessment under local anesthesia
3D knee kinematic assessment under local anesthesia

Locations

Country Name City State
Canada CHUM Montréal Quebec

Sponsors (2)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Correlation of kinematic data with clinical laxity tests 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01674816 - Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration N/A