Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration

(Étude de la cinématique Tridimensionnelle du Genou et Guidage Chirurgical Minimalement Effractifs Par Recalage Rigide échographique)

Problem:

Currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. However, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee.

Hypothesis:

A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.

Objectives :

• Demonstrating the capacity of the system to precisely measure 3D knee kinematics
• Quantifying the reproducibility of the kinematic measurements
• Measuring the impact of knee surgical procedures on knee kinematics
• Assessing the correlations between measured articular kinematics and clinical results after knee surgery
• Integrating the novel measuring system to the surgical flow of three knee surgical procedures
• Quantifying the precision and reproducibility of the surgical actions guided by the system
• Comparing the clinical results of surgeries guided by the system to those performed with the traditional technique

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis; Clinical Outcomes; Knee Instability; 3D Knee Kinematics; Precision of Surgical Actions
• Intervention / Treatment: Device: Repeated Measurements of Knee Alignment and Kinematics; Device: Computer Guidance of Surgical Actions

Detailed Description

A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frédéric Lavoie, MD MSc FRCSC; Phone Number: 25900 1-514-890-8000; Email: fredericlavoiemd@gmail.com
• Study Contact Backup: Name: Fidaa Al-Shakfa, MSc; Phone Number: 26103 1-514-890-8000; Email: f.alshakfa.crchum@gmail.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Principal Investigator: Frédéric Lavoie, MD MSc FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))

Exclusion Criteria:

• Active infection
• Atypical morphology and/or alignment of the lower limbs
• Knee instability (other than secondary to ACL deficiency in patients awaiting ACLR)
• Knee flexion contracture of 10 degrees or more
• Knee flexion of less than 120 degrees

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Repeated Measurements of Knee Alignment and Kinematics; Patients in the Repeated Measurements Arm will have the kinematic measurement protocol repeated twice before and twice after the surgical procedure; the procedure itself will be performed with the traditional technique, i.e without guidance by the system.	Device: Repeated Measurements of Knee Alignment and Kinematics; Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
Active Comparator: Computer Guidance of Surgical Actions; Patients in the Computer Guidance of Surgical Actions Arm will have the kinematic measurement protocol performed only once before and once after the surgical procedure; the procedure itself will be performed with guidance by the system.	Device: Computer Guidance of Surgical Actions; Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D knee kinematic assessment	The system should be able to precisely and reproducibly measure 3D knee kinematics (tibio-femoral flexion, abduction-adduction, transverse rotation, and anterio-posterior and medio-lateral translations)	1 day
Precision of guided surgical actions	The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.	During surgery
Precision of guided surgical actions	The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.	On post-operative imaging (six weeks after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical results	The clinical results after surgery will be assessed using patient questionnaire and clinical examination.	At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results	The clinical results after surgery will be assessed using the International Knee Society score.	At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results	The clinical results after surgery will be assessed using the KOOS score.	At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results	The clinical results after surgery will be assessed using the SF-12 score.	At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results	The clinical results after surgery will be assessed using the Marx activity scale.	At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results	The clinical results after surgery will be assessed through angular and linear measurements using 3D imaging.	At each post-operative visit (six weeks, six months, one year, and two years after surgery)

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Eiffel Medtech
• Investigators: Principal Investigator: Frédéric Lavoie, MD, MSc, FRCSC, CHUM

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 6, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimated): August 29, 2012

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CE12.006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No