Actively Recruiting
Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty
Led by Northwestern University · Updated on 2026-03-24
95
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
M
Medacta International SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Knee replacement surgery can be performed in one of two ways. Traditionally the goal was for the new joint to be in a neutral position with respect to the femur (thigh bone). This is called Mechanical Alignment (MA). The neutral position is different than the human knee's natural position, so MA often requires the surgeon to make additional cuts to the ligaments and other soft tissue around the knee. More recently surgeons have started to place the new joint in a position that more closely replicates the natural alignment of the human knee. This is called Kinemetic Alignment (KA). KA can be done without additional soft tissue dissection but the procedure requires a higher level of precision that can be difficult to achieve in every case. Some studies have found no difference in outcomes between MA and KA, whereas others have found KA to be superior. But these were small studies or studies that did not consider patient-rated outcomes.
CONDITIONS
Official Title
Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient undergoing primary TKA with a medially-stabilized SpheriKA knee system
- Able to read and understand consent form and patient-reported outcome instruments
- Willing to return for follow-up visits
You will not qualify if you...
- Varus or valgus malalignment greater than 15 degrees to the mechanical axis
- Flexion contracture greater than 15 degrees or knee flexion less than 90 degrees
- Body mass index over 40
- Revision total knee arthroplasty or prior knee surgery other than arthroscopy or arthroscopic-assisted ligament reconstruction
- History or diagnosis of inflammatory arthritis
- Infection in the study knee
- Chronic pain
- Chronic opioid use
- Metabolic musculoskeletal disorders other than osteopenia or osteoporosis
- Receiving workers' compensation for the study condition
- Unable to complete questionnaires in English
- Comorbidities that prevent surgery
- Unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Northwestern Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
M
Melissa Shauver, MPH
CONTACT
M
Megan VanDyke, BSN
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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