Actively Recruiting
Kinematic and Mechanical Alignment Randomized Trial
Led by McMaster University · Updated on 2025-05-08
260
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
R
Research Institute of St. Joseph's Hamilton
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Kinematic and Mechanical Alignment Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult aged 18 years or older
- Knee osteoarthritis requiring total knee arthroplasty
- Provide informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
Research Team
K
Kim Madden, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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