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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Device: Repeated Measurements of Knee Alignment and Kinematics
* Device: Computer Guidance of Surgical Actions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Repeated Measurements of Knee Alignment and Kinematics<br>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<br>* Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.<br>|
| Active Comparator: Computer Guidance of Surgical Actions<br>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<br>* Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.<br>|

What is the study measuring?
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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) |