Ultrasonic Guidance System for Knee Surgery

Overseen By Fidaa Al-Shakfa, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Active infection, Atypical morphology, Knee instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system to help surgeons perform knee surgeries with greater precision using 3D imaging and ultrasound guidance. The goal is to determine if this method, called Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration, can better assess knee movement and improve surgical outcomes compared to traditional techniques. Participants will either have their knee alignment measured repeatedly or undergo surgery guided by this new system. Candidates planning to have knee surgery, such as a total knee replacement or ACL reconstruction, and whose knee can bend at least 120 degrees, may be suitable for participation. As an unphased trial, this study offers the chance to contribute to innovative surgical advancements that could enhance precision and outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ultrasonic guidance system is safe for knee surgery?

Research has shown that using ultrasound to guide surgical tools and check knee movement is accurate and non-invasive. This method allows doctors to view the knee's movement in 3D, potentially improving surgical outcomes. Studies have also demonstrated that this system provides precise and consistent measurements, making it reliable for surgeries.

The technology aims to make knee surgeries less invasive, potentially reducing pain and speeding up recovery for patients. Although new for knee surgeries, this system has been used in other procedures and is generally well-tolerated with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to guide knee surgery using an ultrasonic system. Unlike traditional methods that rely heavily on the surgeon's experience and visual estimation, this system offers real-time, three-dimensional guidance to improve precision during surgery. By comparing surgeries with and without this guidance, the trial aims to determine if this technology can lead to better outcomes, such as improved knee alignment and function. This could potentially revolutionize how minimally invasive knee surgeries are performed, making them more accurate and effective.

What evidence suggests that this ultrasonic guidance system is effective for knee surgery?

Research shows that using ultrasound to guide surgical tools and check knee joint movement is accurate and non-invasive. In this trial, participants in the "Computer Guidance of Surgical Actions" arm will undergo procedures guided by a system that uses ultrasound and sensors to reliably track knee movements during surgery. Studies have shown that this method can accurately measure knee movement in 3D, which is crucial for successful surgeries. This technique consistently delivers reliable results, enhancing surgical precision and potentially improving patient outcomes. Meanwhile, participants in the "Repeated Measurements of Knee Alignment and Kinematics" arm will undergo the procedure using the traditional technique, without system guidance. ^{1 6 7 8 9}

Who Is on the Research Team?

Frédéric Lavoie, MD, MSc, FRCSC

Principal Investigator

CHUM

Are You a Good Fit for This Trial?

This trial is for patients scheduled for knee surgery, such as total knee replacement, high tibial osteotomy, or ACL reconstruction. They must not have an active infection, severe knee stiffness or bending issues, instability (except due to ACL problems), or unusual lower limb shape/alignment.

Inclusion Criteria

I am waiting for knee surgery.

Exclusion Criteria

My legs are shaped or aligned unusually.

My knee is unstable for reasons other than a torn ACL.

I cannot bend my knee fully.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Assessment

Kinematic measurement protocol is performed to assess 3D knee kinematics before surgery

1 day

1 visit (in-person)

Surgical Procedure

Surgical procedure performed with or without computer guidance, including bone cuts and guide-wire placement

1 day

1 visit (in-person)

Post-Surgical Assessment

Kinematic measurement protocol is repeated to assess 3D knee kinematics after surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for clinical results and precision of surgical actions through post-operative visits

Two years

Visits at six weeks, six months, one year, and two years post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Computer Guidance of Surgical Actions
• Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration
• Repeated Measurements of Knee Alignment and Kinematics

Trial Overview The study tests a new tool that measures and guides knee movements during surgery using 3D imaging and minimally invasive techniques. It aims to show the tool's precision in measuring kinematics and guiding surgeries compared to traditional methods.

How Is the Trial Designed?

Group I: Repeated Measurements of Knee Alignment and Kinematics Active Control 1 Intervention

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.

Group II: Computer Guidance of Surgical Actions Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Eiffel Medtech

Industry Sponsor

Trials

2

Recruited

40+

Citations

1. withpower.com withpower.com/trial/phase-osteoarthritis-knee-11-2022-f2554

Ultrasonic Guidance System for Knee Surgery · Info for Participants Research shows that using ultrasound for guiding surgical instruments and assessing knee joint movement can be accurate and non-invasive.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12252519/

Quantification of 3D Kinematic Measurements for Knee ... This study evaluates the accuracy and repeatability of the GATOR system, developed by PreciX Pte Ltd. and integrating ultrasound with inertial ...

3. mdpi.com mdpi.com/1424-8220/24/8/2439

A Method to Track 3D Knee Kinematics by Multi-Channel ... This paper introduces a method for measuring 3D tibiofemoral kinematics using a multi-channel A-mode ultrasound system under dynamic conditions.

4. researchgate.net researchgate.net/publication/393494163_Quantification_of_3D_Kinematic_Measurements_for_Knee_Flexion_and_Tibial_Rotation_Using_an_IMU-Based_Sensor_and_Ultrasound_Imaging_System_A_Cadaveric_Study

Quantification of 3D Kinematic Measurements for Knee ... This study evaluates the accuracy and repeatability of the GATOR system, developed by PreciX Pte Ltd. and integrating ultrasound with inertial ...

5. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/10.1002/jeo2.12050

Ultrasound‐based bone tracking using cross‐correlation ... Therefore, the purpose of this study was to develop and validate an ultrasound (US)-based method for measuring knee kinematics during clinical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11053743/

A Method to Track 3D Knee Kinematics by Multi-Channel ... This paper introduces a method for measuring 3D tibiofemoral kinematics using a multi-channel A-mode ultrasound system under dynamic conditions.

7. mdpi.com mdpi.com/1424-8220/25/13/4211

Quantification of 3D Kinematic Measurements for Knee ... This study evaluates the accuracy and repeatability of the GATOR system, developed by PreciX Pte Ltd. and integrating ultrasound with inertial measurement units ...

8. researchgate.net researchgate.net/publication/379774033_A_Method_to_Track_3D_Knee_Kinematics_by_Multi-Channel_3D-Tracked_A-Mode_Ultrasound

A Method to Track 3D Knee Kinematics by Multi-Channel ... This paper introduces a method for measuring 3D tibiofemoral kinematics using a multi-channel A-mode ultrasound system under dynamic conditions.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6003981/

Minimally invasive total knee replacement: techniques and ... In this review, we outlined the definition of minimally invasive surgery (MIS) in total knee replacement (TKR) and described the different surgical approaches ...