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临床试验/NCT02484781
NCT02484781已完成不适用

Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip

Rijnstate Hospital2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Hip maximum internal/external rotation per cycle

研究概览

简要总结

Total hip replacement surgery is a very successful operation with good long-term results. Hip resurfacing arthroplasty is offered as a treatment option for young and active patients with osteoarthritis of the hip. It has been proposed as a treatment option for younger patients because of claims that it preserves femoral bone stock and has better functional outcomes. The assessment of gait after hip replacement surgery may be able to determine functional differences between patients who have undergone total hip replacement / arthroplasty (THA) versus hip resurfacing.

详细描述

A group of 58 patients, part of a ungoing randomized trial comparing resurfacing hip arthroplasty to metal-on-metal total hip arthroplasty, will be invited to a single gait analysis on a trendmill. All patients have reached a follow up of five years. Patient 's gait will be assessed during two walking sessions, in both sessions spatio-temporal, kinetic and kinematic parameters will be recorded.

  • At first when flat walking with increasing speeds to their top walking speed.
  • Secondly: when walking at a fixed speed with an increasing incline to their top walking incline.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient part of randomised controlled trial (RCT) of hip resurfacing versus MoM total hip arthroplasty for symptomatic osteoarthritis of the hip
  • Patient must be able to consent to the study (written informed consent)
  • Patients who are functioning well post-operatively and not under routine follow up
  • Patients who are able to walk without any safety rail assistance on the treadmill

排除标准

  • Patient not originally randomised during an RCT of hip resurfacing versus MoM total hip arthroplasty
  • Patients who suffer from any neurological or musculoskeletal conditions that might make a gait test dangerous.
  • Patients whose cognitive function prevents them from understanding the study
  • Patients who have had or are awaiting revision surgery for their hip

结局指标

主要结局

Hip maximum internal/external rotation per cycle

时间窗: 5 years postoperative

Mean hip kinematics in degrees assessed on a trendmill

Walking cadence

时间窗: 5 years postoperative

Mean steps / minute at top walking speed assessed on a trendmill

Maximum Push off force (N/kg) per cycle

时间窗: 5 years postoperative

Mean ground reaction forces in Newton / kilogram on a trendmill

Mid-stance force (N/kg) per cycle

时间窗: 5 years postoperative

Mean ground reaction forces assessed on a trendmill

Step length

时间窗: 5 years postoperative

Mean step distance in meters at top walking speed assessed on a trendmill

Maximum weight acceptance (N/kg) per cycle

时间窗: 5 years postoperative

Mean ground reaction forces assessed on a trendmill

Top walking speed

时间窗: 5 years postoperative

Mean top walking speed in kilometers / hour assessed on a trendmill

Hip maximum flexion/extension per cycle

时间窗: 5 years postoperative

Mean hip kinematics in degrees assessed on a trendmill

次要结局

  • Postoperative hip functionality after hip arthroplasty.(5 years postoperative)
  • General Health according EurQol-5D(5 years postoperative)
  • Physical activity level according the UCLA-activity score(5 years postoperative)

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Job van Susante

Dr. JLC van Susante

Rijnstate Hospital

研究点 (2)

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