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

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Not yet enrolling

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

Treatments: Device: Computer Guidance of Surgical Actions; Device: Repeated Measurements of Knee Alignment and Kinematics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01674816

CE12.006

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Repeated Measurements of Knee Alignment and Kinematics

Active Comparator group

Description:

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.

Treatment:

Device: Repeated Measurements of Knee Alignment and Kinematics

Computer Guidance of Surgical Actions

Active Comparator group

Description:

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.

Treatment:

Device: Computer Guidance of Surgical Actions