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临床试验/NCT04521842
NCT04521842已完成不适用

Influence of Large Head vs Standard Size During Total Hip Arthroplasty on Gait Analysis - Prospective Randomized Controlled Trial

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016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
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Time of stance phase

研究概览

简要总结

Total hip replacement (THR) is being considered as one of the most effective medical procedures. Since its introduction, there was a worldwide debate over proper implant selection in terms of size, bearing type and shape. The diameter of used femoral heads components grew throughout the years - from 22 mm in the 1960s to 32 mm in the 2000s, which is the most commonly used size nowadays. In recent years there was a visible use of large femoral heads (>=36mm) in several registers. In the USA there was a significant grow in use of this heads rising from 1% in early 200s to even 58% in 2009. There is a strong evidence data and many researchers concerning range of movement, risk of dislocation, functional results, pain and prosthesis wear depending of femoral head size.

In terms of gait characteristics there are several deviations reported concerning both patients with hip osteoarthritis (OA) and following THR. There is a lack of literature concerning influence of used implants on gait parameters and whether this goal of the surgery can be achieved.

The aim of this study was to assess potential differences of lower limb biomechanics during gait in patients following total hip replacement surgery depending on femoral head diameter and compare them to the normal gait of healthy volunteers. As a secondary outcome authors wanted to inspect correlation between gait parameters and patient-reported outcome.

详细描述

Total hip replacement (THR) is being considered as one of the most effective medical procedures. Since its introduction, there was a worldwide debate over proper implant selection in terms of size, bearing type and shape. The diameter of used femoral heads components grew throughout the years - from 22 mm in the 1960s to 32 mm in the 2000s, which is the most commonly used size nowadays. In recent years there was a visible use of large femoral heads (>=36mm) in several registers. In the USA there was a significant grow in use of this heads rising from 1% in early 200s to even 58% in 2009. There is a strong evidence data and many researchers concerning range of movement, risk of dislocation, functional results, pain and prosthesis wear depending of femoral head size.

In terms of gait characteristics there are several deviations reported concerning both patients with hip osteoarthritis (OA) and following THR. It is well-proven that those with hip OA have reduced stride length and reduced cadence, reduced gait velocity, and reduced joint excursion. Patients after THR walk with lower hip-abduction moments, sagittal-plane range of motion. It is believed that it might be a consequence of pain-avoidance mechanism developed as an adaptation for joint disease, which is still present after the surgery. What is more, there are publications, which underline that lower limb biomechanics during gait do not return to normal following THR.

However there is a lack of literature concerning influence of used implants on gait parameters and whether this goal of the surgery can be achieved.

According to authors best knowledge this study is the first to ever describe potential differences in gait parameters between THR performed with standard femoral heads (28-32mm) and large ones (>=36mm).

Aim of the study The aim of this study was to assess potential differences of lower limb biomechanics during gait in patients following total hip replacement surgery depending on femoral head diameter and compare them to the normal gait of healthy volunteers. As a secondary outcome authors wanted to inspect correlation between gait parameters and patient-reported outcome.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Ability to walk for 10 meters
  • •60-80 years of age
  • •Bilateral THR

排除标准

  • •Revision surgeries before and after THR
  • •Any other lower limbs surgeries
  • •Secondary OA
  • •Neurological disorders
  • •Cardiac disorders
  • •Severly impaired balance
  • •Severe dizziness

研究组 & 干预措施

Large size femoral head

Active Comparator

Participants qualified to undergo total hip replacement who will receive large femoral head size implant

干预措施: Total hip replacement (Procedure)

Standard size femoral head implant

Placebo Comparator

Participants qualified to undergo total hip replacement who will receive standard femoral head size implant

干预措施: Total hip replacement (Procedure)

结局指标

主要结局

Time of stance phase

时间窗: at least 3,5 years after surgery

Change from baseline part of stance phase time during gait, measured in percentage

Time of double-stance phase

时间窗: at least 3,5 years after surgery

Change from baseline part of double-stance phase time during gait, measured in percentage

Time of swing phase

时间窗: at least 3,5 years after surgery

Change from baseline part of swing phase time during gait, measured in percentage

Stride length

时间窗: at least 3,5 years after surgery

Change from baseline length of stride during gait, measured in meters

Cadence

时间窗: at least 3,5 years after surgery

Change from baseline number of strides per minute of walking

Mean gait velocity

时间窗: at least 3,5 years after surgery

Change from baseline mean values of gait speed, measured in meters per second

Range of maximal hip extension for both limbs during ending part of mid-stance phase

时间窗: at least 3,5 years after surgery

Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees

Range of pelvic drop in frontal plane on the opposite site of the bearing limb

时间窗: at least 3,5 years after surgery

Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees

次要结局

未报告次要终点

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (1)

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