跳至主要内容
临床试验/NCT06603103
NCT06603103招募中不适用

Prospective Randomized Study Comparing the SpheriKA® (MEDACTA) and Origin® (SYMBIOS) Prostheses During Total Knee Replacement Using the Kinematic Alignment Technique

Clinique du Sport, Bordeaux Mérignac1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Evolution of "forgotten joint score"

研究概览

简要总结

The traditional technique for implanting a total knee prosthesis, known as mechanical alignment, does not aim to preserve the original anatomy and laxity of the knee. Instead, the implants are "systematically" aligned to create a non-naturally straight lower limb. Respectively 20% and 50% of patients with a mechanically aligned total knee prosthesis are dissatisfied with the result, and complain of residual symptoms. A newer, more physiological technique for implanting a total knee prosthesis, known as kinematic alignment, aims to recreate the unique native anatomy and laxity of each patient's knee. The kinematic alignment technique has been shown to reduce the risk of residual symptoms and thus improve the patient's experience of his or her prosthetic knee. As a result of the emergence of the kinematic alignment technique, two manufacturers have developed total knee prosthesis implants specifically for this new insertion technique. A "made-to-measure" total knee prosthesis (ORIGIN® - Symbios, Yverdon-les-Bains, Switzerland) was developed with the aim of reproducing the unique contour of each implanted knee. Another manufacturer opted to develop a generic total knee prosthesis implant (SPHERIKA® - Medacta, Castel San Pietro, Switzerland), but with a design optimized for the kinematic alignment technique. These two models of total knee prosthesis each offer advantages and limitations that need to be assessed. The main aim of this study is therefore to compare the joint perception of these 2 prostheses. It will also look at the clinical and imaging results, the biomechanics of the prosthetic knee during gait, and the muscular strength of knee extension, obtained for these 2 total knee prostheses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with indication for initial total knee replacement
  • Patient affiliated to a social security scheme
  • Patient informed of the study and formally included (informed consent signed) before the first research examination.

排除标准

  • Patient with complex osteoarthritis (e.g. bone loss, history of patellar instability)
  • Patient with contralateral knee prosthesis
  • Patient with symptomatic osteoarthritis (stiffness and/or pain) of a hip or contralateral knee
  • Patient with another condition (acquired pathology) of the lower limbs and/or nervous system that may significantly affect gait quality
  • Patient deprived of liberty by judicial or administrative decision,
  • Patient of legal age under legal protection or unable to express consent.

结局指标

主要结局

Evolution of "forgotten joint score"

时间窗: 2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery

This score consists in 12 questions with a Likert scale from 0 to 5. A high score indicates a high degree of forgetfulness of the prosthesis on the part of the patient.

次要结局

  • Walking ability(2 years after surgery)
  • Frontal alignment of the lower limb(2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery)
  • Evaluation of muscular strength(2 years after surgery)

研究者

发起方
Clinique du Sport, Bordeaux Mérignac
申办方类型
Other
责任方
Sponsor

研究点 (1)

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