Kinematic and Mechanical Alignment Randomized Trial

NCT06787417 | Recruiting Phase 4

• 1 other identifier: KMART
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Knee replacement surgery is the second most common surgery in Canada. People who have very painful knee arthritis usually receive a knee replacement where the surgeon aims to make everyone's knee as straight as possible (called mechanical alignment). Mechanical alignment focuses on making the implant last as long as possible. However, everybody's knee shape is different and we think that it is important to take individual differences into account. A newer technique that is more personalized is called restricted kinematic alignment. This technique customizes the placement of the new knee to reproduce each patient's unique knee shape, which may not be perfectly straight. We think this newer technique may feel more natural, be more stable, and lead to better knee function. Restricted kinematic alignment might last as long or longer than mechanical alignment, but the research that has been conducted to date is not clear. We are conducting this study to help surgeons better understand which technique is better. One of the reasons the existing research is not clear is because new developments in robotic technology now allow surgeons to place knee implants very precisely, which was not done in most previous research. In this study everyone will receive a robot-assisted knee surgery so we can be sure the implants are placed as precisely as possible. The purpose of this trial is to determine whether there are differences in patient outcomes using restricted kinematic alignment rather than the traditionally used mechanical alignment for total knee replacements. Participants who are having total knee replacements will be randomized to receive either a robot-assisted total knee replacement using mechanical alignment, or a robot-assisted total knee replacement using restricted kinematic alignment . We will ask participants to walk in a markerless motion capture system which will measure walking characteristics at pre-op, 6 months postop and 12 months postop. Participants will also complete a series of standardized questionnaires at preop and 6 months, 12 months, and 24 month postop.

Conditions

Total Knee Arthroplasty; Osteoarthritis

Keywords

Total Knee Arthroplasty; Kinematic Alignment; Mechanical Alignment; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Gait Biomechanics

  The primary outcome will be joint angles and walking characteristics (speed, step length, number of steps, consistency between sides) collected using an in-clinic markerless motion capture system. The system uses 10 synchronized optical cameras (60 Hz, Sony RXOII) placed strategically along the clinic hallways to maximize the viewing volume to capture patient movement characteristics. Advanced AI-driven software (Theia Markerless) is used to predict limb segment poses dynamically as the person moves through the space, and, combined with biomechanical modelling algorithms (Visual3D, C-Motion) can be used to accurately represent patient lower extremity 3D joint angles and other kinematic stride characteristics.

  12 months

Secondary Outcomes (4)

• Knee function

  24 months

• Chronic post-surgical pain (CPSP)

  24 months

• Quality of life

  24 months

• Return to Function

  24 months

Other Outcomes (1)

• Safety

  24 months

Study Arms (2)

Mechanical Alignment

ACTIVE COMPARATOR

Procedure: Mechanically-Aligned Arthroplasty

Restricted Kinematic Alignment

EXPERIMENTAL

Procedure: Restricted Kinematically-aligned Arthroplasty

Interventions

Restricted Kinematically-aligned Arthroplasty PROCEDURE

Robot Assisted with Restricted Kinematically-Aligned TKA.

Restricted Kinematic Alignment

Mechanically-Aligned Arthroplasty PROCEDURE

Robot Assisted with Mechanically Aligned TKA.

Mechanical Alignment

Eligibility Criteria

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

You may qualify if:

• Adult aged 18 years or older
• Knee osteoarthritis requiring total knee arthroplasty
• Provide informed consent

You may not qualify if:

• Inability to provide informed consent (e.g. cognitive disability, language barrier)
• Revision knee surgery
• Simultaneous bilateral knee surgery
• Recent lower extremity surgery or trauma interfering with gait assessment
• A CT scan cannot be obtained prior to surgery
• Inability or unwillingness to comply with the study protocol

Sponsors & Collaborators

• McMaster University: lead
• Research Institute of St. Joseph's Hamilton: collaborator
• Canadian Orthopaedic Foundation (funding): collaborator

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Kim Madden, PhD

CONTACT

289-237-7380; maddenk@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

CA (1)