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Procedure
Ultrasonic Guidance System for Knee Surgery
N/A
Waitlist Available
Led By Frédéric Lavoie, MD, MSc, FRCSC
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on post-operative imaging (six weeks after surgery)
Awards & highlights
Study Summary
This trial is testing a new system for measuring and guiding knee surgery that is less invasive and more accurate than current methods. The study will test the system's ability to measure knee movement, reproducibility, impact on knee surgery, and correlation with clinical results.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves surgical procedures, potential side effects may include typical surgical risks like pain at the incision site, bleeding, infection risk post-surgery, swelling around the knees and possible impact on mobility during recovery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am waiting for knee surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on post-operative imaging (six weeks after surgery)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on post-operative imaging (six weeks after surgery)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
3D knee kinematic assessment
Precision of guided surgical actions
Secondary outcome measures
Clinical results
Trial Design
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.
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Who is running the clinical trial?
Eiffel MedtechIndustry Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying 3D Knee Kinematics
10 Patients Enrolled for 3D Knee Kinematics
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,607 Total Patients Enrolled
1 Trials studying 3D Knee Kinematics
10 Patients Enrolled for 3D Knee Kinematics
Frédéric Lavoie, MD, MSc, FRCSCPrincipal InvestigatorCHUM
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My knee cannot fully straighten by 10 degrees or more.I currently have an infection.I am waiting for knee surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Repeated Measurements of Knee Alignment and Kinematics
- Group 2: Computer Guidance of Surgical Actions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any more participants being enrolled in this research initiative?
"According to the clinicaltrials.gov listing, this medical study is no longer searching for patients; it was first published on December 1st 2023 and last revised on November 10th 2022. Despite that, there are still 698 other trials actively seeking participants at present."
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