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Compensation: Varies

Number of Visits: 3

30 Participants Needed

Ultrasonic Guidance System for Knee Surgery

Overseen ByFidaa 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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Ultrasonic Guidance System for Knee Surgery?

Research shows that using ultrasound for guiding surgical instruments and assessing knee joint movement can be accurate and non-invasive. For example, a study demonstrated that ultrasound can accurately align surgical tools with preoperative plans, and another study showed it can precisely measure knee joint motion without needing invasive procedures.¹ ² ³ ⁴ ⁵

Is the Ultrasonic Guidance System for Knee Surgery safe for humans?

The research articles focus on the accuracy and technical aspects of ultrasound-based systems for surgical guidance, but they do not provide specific safety data for human use. The studies involve cadaveric and phantom models, which means they have not been tested for safety in living humans.¹ ² ³ ⁴ ⁶

How is the Ultrasonic Guidance System for Knee Surgery treatment different from other knee surgery treatments?

This treatment is unique because it uses a non-invasive ultrasound-based system to guide knee surgery, allowing for precise 3D kinematic analysis without the need for implanting markers into the bones, which is typically required for accurate measurements.¹ ² ⁶ ⁷ ⁸

What is the purpose of this trial?

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

Research Team

Frédéric Lavoie, MD, MSc, FRCSC

Principal Investigator

CHUM

Eligibility Criteria

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.

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Timeline

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

Treatment Details

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.

Participant Groups

2Treatment groups

Active Control

Group I: Repeated Measurements of Knee Alignment and KinematicsActive Control1 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 ActionsActive Control1 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.