跳至主要内容
临床试验/NCT03975673
NCT03975673Unknown不适用

Kinematic vs Mechanical Alignment Technique for Primary Total Hip Replacement in Patient With Hip Arthritis: a Prospective Comparative Non Randomised Study

Centre de l'arthrose, Paris1 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
460
试验地点
1
主要终点
Dislocation rate

研究概览

简要总结

Background

  • In the 19th century, Sir John Charnley successfully introduced total joint replacements for hips. In order to prevent implant fixation failure and accelerated polyethylene wear, it was initially recommended that implants were systematically positioned in a "biomechanically-friendly" way, which disregarded most of the individual anatomy (medialized acetabular cup, systematized cup version and inclination, etc.)
  • While those initial surgical techniques made popular and clinically successful total joint replacements, many complications (aseptic loosening, pain, excessive wear) have remained and mainly the persistence of frequent instability after THA. In response to those complications, many improvements were developed in the area of joint replacement over the last few decades, with one the most recent dating from 2017 and being the development of a surgical technique Rationale
  • The kinematic alignment (KA) technique for total hip arthroplasty (THA) aims at restoring the acetabular center of rotation and as much as possible the constitutional acetabular anteversion by using the transverse acetabular ligament (TAL) as a reference landmark. Also, the technique aims (1) at making personalized choice for the hip component design, (2) at defining the cup positioning, and (3) at sometimes considering additional spine surgery based on the assessment of the individual spine-hip relation.
  • KA techniques for hip replacements are relatively new, likely to become popular over time, and their true value remains to be determined.

详细描述

  • Objective: Evaluation of the kinematic alignment technique for hip prostheses in patient with hip osteoarthritis
  • Hypothesis: the consideration of hip pathoanatomy and lumbo-pelvic kinematic disorder when planning a hip replacement is likely to decrease the risk of prosthetic dislocation and improve patient function and satisfaction

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Osteoarthritic hip patients eligible for primary total hip arthroplasty (THR).
  • •> 18 years-old with no upper age limit
  • •Affiliated to a social security scheme

排除标准

  • •Pregnant or lactating women or in age to procreate without contraceptive treatment
  • •History of mental illness or neurological deficit or adults lacking capacity to consent for themselves
  • •Prisoners or young offenders
  • •Persons who might not adequately understand verbal explanations or written information given in French, or who have special communication needs
  • •Subjects having been or being frequently x-ray examination
  • •Heart failure with risk of exercise angina or comorbidity(ies) significantly affecting patient function
  • •Any participants who are involved in current research or have recently been involved in any research prior to recruitment.

研究组 & 干预措施

Conventional Total Hip Replacement (cTHR )

Active Comparator

Osteoarthritic patient undergoing the conventional technique

  • medializing the hip center of rotation
  • obtain a standing acetabular cup position fitting the Lewinneck recommendations (inclination 40°±10°, version 15°±10°)

干预措施: hip replacement (Procedure)

Kinematically Aligned Total Hip Replacement (KATHR )

Experimental

Osteoarthritic patient undergoing the kinematically aligned technique

  • restoring the acetabular center of rotation
  • restoring the constitutional acetabular anteversion by using the transverse acetabular ligament (TAL) as a reference landmark.
  • making personalized choice for the hip component design
  • considering additional spine surgery based on the assessment of the individual spine-hip relation.

干预措施: hip replacement (Procedure)

结局指标

主要结局

Dislocation rate

时间窗: Occurrence within the first year after primary total hip replacement

The rates of occurrence of hip dislocation (treated in the hospital or in an outpatient setting).

次要结局

  • EuroQualityOfLife 5 dimension index (EQ5D)(Preoperative, postoperative 6 months and 12 months . assessment for all parameters.)
  • Oxford hip score (OHS)(Preoperative, postoperative 6 months and 12 months . assessment for all parameters.)
  • satisfaction visual analogic scale (VAS)(Preoperative, postoperative 6 months and 12 months . assessment for all parameters.)
  • Implant positioning parameter(Preoperative, postoperative 6 months and 12 months . assessment for all parameters.)

研究者

发起方
Centre de l'arthrose, Paris
申办方类型
Other
责任方
Sponsor

研究点 (1)

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