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临床试验/NCT03378986
NCT03378986已完成不适用

Functional Recovery After Monolateral or Bilateral Total Hip Arthroplasty

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1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
40
试验地点
1
主要终点
Change in Centre of Pressure Length of Trace

研究概览

简要总结

This is an observational prospective study aimed to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.

详细描述

Introduction

Total hip arthroplasty (THA) represents a successful treatment for several hip joint pathologies. In case of bilateral hip joint involvement, the advancements in surgical techniques have made the development of bilateral THA surgery possible through one-stage procedure. This approach seems to be as safe as unilateral THA and safer than two-stage bilateral THA, but few studies considering functional outcomes in these patients without exploring outcomes linked to their motor and functional performance.

Objective

the aim of the study is to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.

Methods: 20 patients underwent to unilateral THA and 20 patients underwent to simultaneous bilateral THA will be recruited in the study. The partecipants will be aged from 40 to 65 years old, they will be undergone to primary THA for arthritis and the will be able to walk for 50 m without aids. Patients with severe dysplasia (Crowe III and IV), anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint, with traumatic event, or previous femoral and / or pelvic osteotomy, will be excluded from the study. Weight distribution and postural stability will be evaluated asking to participants to stay on two stabilometric platform with open eyes and closed eyes for 45 seconds. Gait analysis will be used to evaluate the spatio-temporal gait parametres and the ankle, knee, hip and pelvic kinematic. Pain during walking and patients' walking ability will be also evaluated throught Numeric Rating Scale (NRS) and Timed Up and Go test (TUG). Outcome measures will be collected the day before surgery, after three, seven and about forty days after surgery, except for gait analysis and Time Up and Go tests, which will not be recorded after three days.

Statistical analysis

normality and homogeneity of demographic variables and outcome measures at the baseline will be verified. Intergroup and intra-group post-intervention differences related to outcome measures will be investigated through ANOVA for repeated measurements including post hoc analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • from 40 to 65 years old
  • primary THA for osteoarthritis
  • ability to walk for 50 m without aids

排除标准

  • severe dysplasia (Crowe III and IV)
  • anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint
  • traumatic event
  • previous femoral and / or pelvic osteotomy

结局指标

主要结局

Change in Centre of Pressure Length of Trace

时间窗: Before surgery, 3rd and 7th postoperative day

Ability to mantain balance

Change in Weight Distribution

时间窗: Before surgery, 3rd and 7th postoperative day

Ability to simmetrically load their lower limbs

次要结局

  • Gait analysis(Before surgery and 7th postoperative day)
  • Change in Numeric Rating Scale(Before surgery, 3rd and 7th postoperative day)
  • Change in Timed Up and Go Test(Before surgeryand 7th postoperative day)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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