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Search / Trial NCT04226339

Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment

Launched by HOSPICES CIVILS DE LYON · Jan 10, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Total Knee Arthroplasty Prosthesis Kinetic Alignment Mechanical Alignment

ClinConnect Summary

This clinical trial is studying two different approaches to total knee arthroplasty, also known as knee replacement surgery, to see which method helps patients walk better after their operation. One approach is called "kinematic alignment," which aims to match the surgery to the patient's natural knee shape and function, while the other is "mechanical alignment," which uses a standard positioning for the artificial knee. The goal is to determine if the kinematic alignment leads to improved walking patterns compared to the traditional method.

To participate in this study, you need to be an adult aged 55 to 80 with specific knee arthritis issues and a slight inward knee deformity. You should be able to perform a walking test and understand the study requirements. If you join, you can expect to receive a new knee prosthesis and be monitored for your walking ability after the surgery. This research aims to improve patient satisfaction and outcomes for those undergoing knee replacement, as many patients have expressed dissatisfaction with their current knee prostheses.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Both sex
  • Adults between 55 and 80 years
  • Diagnosis of internal or global disabling femorotibial gonarthrosis Indication of total first knee arthroplasty (unilateral), using a Sphere type prosthesis (Medacta)
  • Constitutional deformity in varus between 3 ° and 10 °
  • Fulfilling the pass conditions of a KneeKG walking test: Unipodal support possible for 1 minute, run for 5 min at a speed of at least 0.8 km / h
  • Affiliated to a social security system
  • Patients able to understand and fulfill the requirement of the study
  • Exclusion Criteria:
  • TKA bilateral
  • TKA to change an Uni-compartmental prosthesis
  • History of femoral or tibial fracture
  • History of femoral or tibial osteotomy
  • Associated gesture at the same time (allograft, osteotomy)
  • External femorotibial gonarthrosis
  • Angle Hip Knee Ankle \> 178 °
  • Constitutional distortion\> 10 °
  • Refusal to participate in the study
  • Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research
  • Adults subject to a legal protection measure
  • breastfeeding or pregnant women
  • Patient already participating to another clinical trial that might jeopardize the current trial

About Hospices Civils De Lyon

Hospices Civils de Lyon (HCL) is a leading public health institution in France, dedicated to providing high-quality healthcare and advancing medical research. With a rich history dating back to the 18th century, HCL encompasses multiple hospitals and offers a diverse range of services across various medical specialties. The institution is committed to fostering innovative clinical trials that aim to enhance patient care and improve therapeutic outcomes. By collaborating with academic and industry partners, HCL plays a pivotal role in the development of new treatments and the advancement of medical knowledge, ensuring that research efforts are aligned with the highest ethical standards and patient safety protocols.

Locations

Lyon, , France

Patients applied

0 patients applied

Trial Officials

Sebastien Lustig, Pr

Principal Investigator

Hospices Civils de Lyon

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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