3D Knee Kinematics, Clinical Outcomes, Knee Instability, Knee Osteoarthritis, Precision of Surgical Actions
Conditions
Brief 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
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.
Interventions
DEVICERepeated Measurements of Knee Alignment and Kinematics
Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
DEVICEComputer Guidance of Surgical Actions
Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.
Sponsors
Eiffel Medtech
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3D knee kinematic assessment | 1 day | 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) |
| Precision of guided surgical actions | During surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical results | At each post-operative visit (six weeks, six months, one year, and two years after surgery) | The clinical results after surgery will be assessed using patient questionnaire and clinical examination. |
Countries
Canada
Contacts
Primary ContactFrédéric Lavoie, MD MSc FRCSC
Backup ContactFidaa Al-Shakfa, MSc
Outcome results
None listed