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Procedure
Mechanical vs Anatomical Alignment in Knee Replacement
N/A
Waitlist Available
Led By Pascal Andre Vendittoli, MD, MSc
Research Sponsored by Maisonneuve-Rosemont Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient qualifies for primary TKA
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the effects of two implant techniques in knee replacement surgery: standard practice vs. kinematic alignment, which may improve ROM, pain, biomechanics & patient satisfaction.
Who is the study for?
This trial is for adults who need a total knee replacement (TKA) and can give informed consent. It's not for those under 18, with infections in the leg, severe knee instability or deformity, hip replacements on the same side, substance abuse issues, mental disorders, pregnant women, allergies to implant materials, neuromuscular diseases affecting the limb or other lower limb joint damage.Check my eligibility
What is being tested?
The study compares two ways of aligning knee implants during surgery: 'Mechanical TKA' aligns components perpendicular to the mechanical axis; 'Anatomical TKA' aims to restore natural kinematics by matching prearthritic orientation. The goal is to see which method leads to better recovery and patient satisfaction without compromising implant longevity.See study design
What are the potential side effects?
While specific side effects are not listed here as it depends on individual cases and surgical outcomes may vary widely from person-to-person. Generally speaking though potential risks include pain at site of surgery infection stiffness or difficulty moving your new joint bleeding blood clots nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for a total knee replacement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Component migration measured with Radiostereophotometry
Secondary outcome measures
Clinical scores
Knee kinematics measured with the Knee KG (Emovi inc.)
Rehabilitation
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AnatomicalExperimental Treatment1 Intervention
67 subjects will be randomized to receive an Anatomical TKA with the My knee instruments and a GMK sphere device.
Group II: MechanicalActive Control1 Intervention
67 subjects will be randomized to receive a Mechanical TKA with the My knee instruments and the GMK sphere device.
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Who is running the clinical trial?
Maisonneuve-Rosemont HospitalLead Sponsor
99 Previous Clinical Trials
36,189 Total Patients Enrolled
Pascal Andre Vendittoli, MD, MScPrincipal InvestigatorResearch Director and surgeon
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have damage to the joints in my legs.I am eligible for a total knee replacement.I have a condition that affects my muscles and the nerves controlling them.You are unable to undergo a CT-scan due to medical reasons.I have an infection that is getting worse.I have had a hip replacement on the affected side.You have a history of alcohol or drug abuse.You are allergic to the materials used in the implant.My knee is deformed and affects how my leg is shaped.I have severe joint instability due to damage or loss of key structures.You have a mental illness or psychiatric disorder.I have muscle loss or disease that makes surgery on my limb not worth it.You understand what will happen during the study.You are pregnant.I have an infection in my leg.I am under 18 years old.I am able to understand and agree to the study's procedures and risks.
Research Study Groups:
This trial has the following groups:- Group 1: Mechanical
- Group 2: Anatomical
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.
Does this scientific experiment still have openings for participants?
"Clinicaltrials.gov displays that this study is no longer recruiting patients, with the initial posting of April 13th 2015 and last update on August 30th 2018. Nevertheless, there are 6 other medical trials actively enrolling individuals presently."
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