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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
Must not have
Other joint damage of the lower limbs
Any neuromuscular disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am eligible for a total knee replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have damage to the joints in my legs.
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I have a condition that affects my muscles and the nerves controlling them.
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I have an infection that is getting worse.
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I have had a hip replacement on the affected side.
Select...
My knee is deformed and affects how my leg is shaped.
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I have severe joint instability due to damage or loss of key structures.
Select...
I have muscle loss or disease that makes surgery on my limb not worth it.
Select...
I have an infection in my leg.
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Component migration measured with Radiostereophotometry
Secondary study objectives
Clinical scores
Knee kinematics measured with the Knee KG (Emovi inc.)
Rehabilitation
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Find a Location

Who is running the clinical trial?

Maisonneuve-Rosemont HospitalLead Sponsor
101 Previous Clinical Trials
38,193 Total Patients Enrolled
Pascal Andre Vendittoli, MD, MScPrincipal InvestigatorResearch Director and surgeon

Media Library

Anatomical TKA (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02256904 — N/A
Personal Satisfaction Research Study Groups: Mechanical, Anatomical
Personal Satisfaction Clinical Trial 2023: Anatomical TKA Highlights & Side Effects. Trial Name: NCT02256904 — N/A
Anatomical TKA (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02256904 — N/A
~13 spots leftby Dec 2025
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