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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01674816
• Other study ID #: CE12.006
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2025
• Est. completion date: December 1, 2026

Study information

• Verified date: February 2024
• 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
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 3D Knee Kinematics
• Clinical Outcomes
• Knee Instability
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Precision of Surgical Actions

Intervention

Device:
• Repeated Measurements of Knee Alignment and Kinematics
Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
• Computer Guidance of Surgical Actions
Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	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 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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)