Mechanically or Kinematically Aligned Total Knee Prosthesis

Официальное название

Mechanically or Kinematically Aligned Total Knee Prosthesis: Prospective and Comparative Study of Clinical, Stereoradiographic, and Biomechanical Results

Обзор

The mechanical alignment technique (Mechanical Alignment - MA) of a total knee prosthesis (TKA) was developed with the aim of making the installation of a TKA simple and reproducible, and that the prosthetic biomechanics are acceptable, thus promoting good longevity of implants. This is a technique that does not aim to restore the constitutional anatomy of the knee; bone cuts are systematically made at fixed angles, in the 3 planes of space, in relation to the mechanical axes of the long bones (femur and tibia). This non-personalized implantation technique therefore systematically alters the anatomy, laxity and kinematics of the knee, causing up to 50% of residual symptoms after prosthetic implantation and 20% of dissatisfied patients. In order to improve the clinical results of TKA, a new, more personalized and physiological technique was developed in 2007, called Kinematic Alignment (KA). This technique aims to restore the pre-arthritic anatomy, unique to each knee. Patients with severe constitutional deformity of the lower limb therefore retain this deformity after kinematic prosthetic replacement. The impact of the alignment technique on the biomechanics of the prosthetic knee remains poorly described. The main objective of this study is therefore to compare knee biomechanics between mechanical TKA and kinematic TKA.

Вмешательства

• Устройство kinematic knee prosthesis
  Patients with a kinematically aligned total knee prosthesis and having a post-operative follow-up consultation within at least 1 year after their surgery are consecutively pre-selected according to the eligibility criteria.
• Устройство biomechanic knee prosthesis
  A group of patients with a mechanically aligned TKA and scheduled for a follow-up consultation 1 year after surgery will be identified to be matched on the aforementioned criteria (sex, age, BMI).

Первичные конечные точки

• Biomechanical parameters of knee : spatiotemporal parameters [Срок оценки: One year after surgery]
• Biomechanical parameters of knee : Kinematic parameters in the 3 planes of space [Срок оценки: One year after surgery]
• Biomechanical parameters of knee : joint moments [Срок оценки: One year after surgery]
• Biomechanical parameters of knee : force [Срок оценки: One year after surgery]
• Biomechanical parameters of knee : lever arms [Срок оценки: One year after surgery]
• Symmetry index between the operated limb and the healthy controlateral limb [Срок оценки: One year after surgery]

Вторичные конечные точки (12)

• Clinical results : Patient-Reported Outcome Measures: Functional score (OXFORD scale) [Срок оценки: One year after surgery]
• Clinical results : Patient-Reported Outcome Measures: joint perception score [Срок оценки: One year after surgery]
• Clinical results : Patient-Reported Outcome Measures: pain [Срок оценки: One year after surgery]
• Clinical results : Patient satisfaction [Срок оценки: One year after surgery]
• Clinical results : range of mobility of the prosthetic knee [Срок оценки: One year after surgery]
• Clinical results : complication rate [Срок оценки: One year after surgery]
• Imaging results : EOS 3D, alignement of the lower limb [Срок оценки: One year after surgery]
• Imaging results : EOS 3D, orientation of the implants [Срок оценки: One year after surgery]
• Imaging results : EOS 3D, distance between anterior femoral cortex and prosthetic trochlea [Срок оценки: One year after surgery]
• Imaging results : radiography, evaluation of implant fixation [Срок оценки: One year after surgery]
• Imaging results : radiography, measurement of patellar height [Срок оценки: One year after surgery]
• Imaging results : radiography, evaluation of the bone structure [Срок оценки: One year after surgery]

Критерии участия

Критерии включения

• Patient followed as part of a consultation 1 year after TKA placement
• Adult patient
• Patient affiliated to a social security system
• Patient informed of the study and formally included (signing of informed consent) before the first research review

Критерии исключения

• Patient with a contralateral knee prosthesis
• Patient with another condition (acquired pathology) of the lower limbs (e.g. severe osteoarthritis of the contralateral knee or hip/ankle) and/or of the nervous system (e.g. Parkinson's) which may significantly affect the quality of walking
• Pregnant patient
• Patient deprived of liberty by judicial or administrative decision,
• Adult patient subject to a legal protection measure or unable to express consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Clinique du Sport Bordeaux Merignac — Mérignac

Идентификаторы

NCT: NCT06158646 · 2023-A01312-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗