NCT06787417 Kinematic and Mechanical Alignment Randomized Trial
| NCT ID | NCT06787417 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | McMaster University |
| Condition | Total Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 260 participants in total. It began in 2025-02-20 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06787417 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06787417 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06787417 currently recruiting?
Yes, NCT06787417 is actively recruiting participants. Contact the research team at maddenk@mcmaster.ca for enrollment information.
Where is the NCT06787417 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT06787417 clinical trial?
NCT06787417 is sponsored by McMaster University. The trial plans to enroll 260 participants.