Comparing two knee replacement techniques for better outcomes
Kinematic and Mechanical Alignment Randomized Trial (KMART): A Technology-Focused Randomized Controlled Trial
This study is testing two different knee replacement techniques to see which one helps people with knee osteoarthritis feel better and move more easily after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT06787417 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two different surgical techniques for total knee arthroplasty: mechanical alignment and restricted kinematic alignment. Mechanical alignment aims for a straight knee to enhance implant longevity, while restricted kinematic alignment customizes the knee replacement to fit each patient's unique anatomy. The study will assess patient satisfaction, functional outcomes, and knee motion to determine which approach yields better results. By utilizing robotic-assisted surgery, the trial aims to provide more personalized treatment options for patients with knee osteoarthritis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with knee osteoarthritis requiring total knee arthroplasty.
Not a fit: Patients who have cognitive disabilities, language barriers, or those undergoing revision knee surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient satisfaction and functional outcomes after knee replacement surgery.
How similar studies have performed: Previous studies have shown comparable outcomes between mechanical and kinematic alignment, but this trial aims to clarify the benefits of personalized approaches.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamilton, Ontario
- St. Joseph's Healthcare — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Kim Madden, PhD
- Email: maddenk@mcmaster.ca
- Phone: 289-237-7380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.