Recruiting

Kinematic & Mechanical

Sponsor:

McMaster University

Code:

NCT06787417

Conditions

Total Knee Arthroplasty

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Restricted Kinematically-aligned Arthroplasty

Mechanically-Aligned Arthroplasty

Study Details

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

Study ID

NCT06787417

Start date

Feb 20, 2025

Status verified date

May, 2025

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Mechanical Alignment

experimental: Restricted Kinematic Alignment

Interventions

Restricted Kinematically-aligned Arthroplasty

Robot Assisted with Restricted Kinematically-Aligned TKA.

Mechanically-Aligned Arthroplasty

Robot Assisted with Mechanically Aligned TKA.

Primary outcome measure

  • Gait Biomechanics [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Healthcare

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Principal Investigator:

Anthony Adili, MD, P.Eng, FRCSC

More Information

Sponsor

McMaster University

Last update posted

May 8, 2025

Last verified

May, 2025

Keywords

  • Total Knee Arthroplasty
  • Kinematic Alignment
  • Mechanical Alignment
  • Osteoarthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2025-05-08.