134 Participants Needed

Mechanical vs Anatomical Alignment in Knee Replacement

PV
DL
Overseen ByDaniel Lusignan, Nurse
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Maisonneuve-Rosemont Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Current practice in orthopedics is to recommend TKA implantation with the femoral and tibial components perpendicular to their mechanical axis. Therefore, current surgical technique does not replicate natural knee anatomy and biomechanics. An alternative alignment method that attempts to replicate the kinematics of the knee is " kinematic alignment ". The principle behind kinematic alignment is placement of the TKA components so that the orthogonal 3-D orientation of the 3 axes that describe normal knee kinematics is restored to that of the prearthritic knee. Theoretical benefits of kinematic alignment include less ligamentous release to balance the knee intra-operatively, more rapid recovery, better range of motion (ROM), less post-operative pain, better knee biomechanics, and improved patient satisfaction. However, a major concern is that there are no mid- or long-term data on implant survivorship (absence of loosening) in TKA based on "anatomical" implantation. The investigators propose to compare the clinical results of TKA implanted with mechanical alignment (standard practice) to kinematic alignment, in a double-blind, randomized trial.

Research Team

PA

Pascal Andre Vendittoli, MD, MSc

Principal Investigator

Research Director and surgeon

Eligibility Criteria

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.

Inclusion Criteria

I am eligible for a total knee replacement.
You understand what will happen during the study.
I am able to understand and agree to the study's procedures and risks.

Exclusion Criteria

I have damage to the joints in my legs.
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.
See 11 more

Treatment Details

Interventions

  • Anatomical TKA
  • Mechanical TKA
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Maisonneuve-Rosemont Hospital

Lead Sponsor

Trials
102
Recruited
38,300+