Comparing two methods of knee replacement surgery
Official title: A Prospective, Randomized, Single-blinded Clinical Trial Comparing Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty Using Medacta Spherika
Run by Northwestern University · NCT06617871 · Data updated 2026-11-12
This study is testing two different knee replacement surgery techniques to see which one makes patients feel better and have better results after their operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 79 Years |
| Sex | All |
| Enrollment | 95 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | July 2028 |
| Study ends | December 2028 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT06617871 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients undergoing primary total knee arthroplasty with a specific knee system and who can understand and complete follow-up assessments.
✕Probably not a fit
Patients with significant malalignment, severe obesity, or prior knee surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares two surgical techniques for total knee arthroplasty: Mechanical Alignment (MA) and Kinematic Alignment (KA). MA positions the new joint in a neutral position, often requiring additional soft tissue adjustments, while KA aims to replicate the natural alignment of the knee without extensive dissection. The study seeks to determine which method leads to better patient satisfaction and outcomes, particularly focusing on patient-rated results. By analyzing the effectiveness of these approaches, the trial aims to address the dissatisfaction experienced by some patients post-surgery.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that enhance patient satisfaction and reduce chronic pain after knee replacement.
How similar studies have gone: Previous studies comparing these alignment techniques have shown mixed results, indicating that this area of research is still evolving.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient undergoing primary TKA with a medially-stabilized SpheriKA knee system * Able to read and understand consent form and PRO instruments and willing to return for follow up visits Exclusion Criteria: * Varus or Valgus malalignment \>15 degrees to mechanical axis * Flexion contracture \>15 degrees or flexion \<90 degrees * BMI \>40 * Revision TKA or other prior knee surgery other than arthroscopy or arthroscopic-assisted ligament reconstruction * Diagnosis or history of any of the following * inflammatory arthritis * infection in study knee * chronic pain * chronic opioid use * metabolic musculoskeletal disorder other than osteopenia/osteoporosis * Patients receiving workers' compensation for study condition * Patients who cannot complete questionnaires in English * Patients with comorbidities preventing surgery * Patients who are not able to provide informed consent
Where it's running
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Northwestern Medicine
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Adam Edelstein, MD — Assistant Professor of Orthopaedic Surgery
- Study coordinator: Melissa Shauver, MPH
- Email: melissa.shauver@northwestern.edu
- Phone: 312-472-6024
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.