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Search / Trial NCT06617871

Mechanical Alignment Vs Kalipered Kinematic Alignment Total Knee Arthroplasty

Launched by NORTHWESTERN UNIVERSITY · Sep 25, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Randomized Trial Knee Arthroplasty

ClinConnect Summary

This clinical trial is comparing two different methods of knee replacement surgery for patients suffering from knee osteoarthritis. The traditional approach, called Mechanical Alignment (MA), aims to place the new knee joint in a straight position, which can sometimes require extra adjustments to the surrounding tissues. The newer method, known as Kinematic Alignment (KA), seeks to position the knee more naturally, like the way a healthy knee works, and does so with less alteration to the surrounding tissues. Researchers want to understand which method leads to better outcomes for patients, particularly from the patients' own perspectives.

To participate in this study, participants should be adults planning to have their first total knee replacement surgery using a specific knee system. They should be able to read and understand the study materials and be willing to come back for follow-up visits. However, there are certain conditions that might exclude someone from joining, such as severe misalignment of the knee, prior knee surgeries (except minor ones), or serious health issues. Those who join can expect to receive one of the two surgical methods and will be asked to provide feedback on their recovery and knee function after the surgery. This study aims to gather more information about the best practices for knee replacements, ultimately helping future patients.

Gender

ALL

Eligibility 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

About Northwestern University

Northwestern University is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a robust infrastructure that supports interdisciplinary collaboration, Northwestern leverages its expertise in various fields, including medicine, engineering, and social sciences, to drive groundbreaking studies. The university is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and focus on participant safety. Through its Clinical Trials Office, Northwestern aims to translate scientific discoveries into effective therapies, ultimately enhancing health outcomes and contributing to the broader medical community.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Adam Edelstein, MD

Principal Investigator

Assistant Professor of Orthopaedic Surgery

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported