Actively Recruiting

Phase Not Applicable
Age: 21Years - 79Years
All Genders
NCT06617871

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

Age: 21Years - 79Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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