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

NCT02256904 | Unknown

• 1 other identifier: HMR 01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alignment; Kinematic; knee; satisfaction; function; survivorship

Outcome Measures

Primary Outcomes (1)

• Component migration measured with Radiostereophotometry

  In the first 40 cases (20 in each group), we will compare the migration with a RSA system between anatomically- and mechanically-aligned implants at 2 years and predict the long-term survivorship of total knee prostheses inserted with these two techniques.

  2 years

Secondary Outcomes (4)

• Clinical scores

  2 years

• Knee kinematics measured with the Knee KG (Emovi inc.)

  2 years

• Technical benefits

  1 month

• Rehabilitation

  1 month

Study Arms (2)

Anatomical

EXPERIMENTAL

67 subjects will be randomized to receive an Anatomical TKA with the My knee instruments and a GMK sphere device.

Procedure: Anatomical TKA

Mechanical

ACTIVE COMPARATOR

67 subjects will be randomized to receive a Mechanical TKA with the My knee instruments and the GMK sphere device.

Procedure: Mechanical TKA

Interventions

Anatomical TKA PROCEDURE

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.

Anatomical

Mechanical TKA PROCEDURE

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.

Mechanical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient qualifies for primary TKA
• Patient understands the study conditions
• Patient is capable of giving informed consent

You may not qualify if:

• Other joint damage of the lower limbs
• Extra-articular knee deformation of the lower limb
• Hip arthroplasty on the surgical side
• Contraindication to CT-scan
• Acute or chronic infection of the lower limb
• Progressive local or systemic infection
• Alcohol or drug abuse
• Psychiatric illness/mental disorder
• Pregnancy
• Less than 18 years of age
• Known allergy to the implant materials
• Muscular loss, neuromuscular disease or vascular deficiency of the affected limb making the operation unjustifiable
• Any neuromuscular disorder
• Severe instability secondary to advanced destruction of osteochondral structures or loss of integrity of the lateral ligament

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Personal Satisfaction; Genu Varum

Condition Hierarchy (Ancestors)

Behavior; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Pascal Andre Vendittoli, MD, MSc

  Research Director and surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical researcher, MD, MSc, FRCSC

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 6, 2014
• Study Start: April 13, 2015
• Primary Completion: October 15, 2019
• Study Completion: January 1, 2025
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

CA (1)