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RSA and Clinical Comparison of Anatomical and Mechanical Alignment in Total Knee Replacement

NCT02256904 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2023-03-17

No results posted yet for this study

Summary

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.

Conditions

  • Personal Satisfaction
  • Genu Varum

Interventions

PROCEDURE

Anatomical TKA

Personalized Medacta plastic cutting blocks will be manufactured according to patient Ct-scan.The anatomical cutting blocks will be design to resurface the femoral and tibial bones to restore each patient's pre-arthritic anatomy within specific margins: maximum of 5 degrees valgus/varus tibial or femoral cut and overall lower limb alignment within +/-3 degrees of varus/valgus). GMK sphere TKA will be implanted using the manufactured cutting blocks.

PROCEDURE

Mechanical TKA

Personalized Medacta plastic cutting blocks will be manufactured according to patient Ct-scan. In the mechanical group, femoral and tibial cutting blocks will be designed for a 0-degree angle according to the mechanical axis. Femoral rotation will be aligned with the femoral trans-epicondylar axis. Tibial rotation will follow femoral rotation. GMK sphere TKA will be implanted using the manufactured cutting blocks.

Sponsors & Collaborators

  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Pascal Andre Vendittoli, MD, MSc · Research Director and surgeon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-13
Primary Completion
2019-10-15
Completion
2025-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02256904 on ClinicalTrials.gov