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临床试验/NCT07086716
NCT07086716招募中不适用

The Role of Frailty in the Rehabilitation Pathway Following Hip or Knee Arthroplasty Surgery.

Joel Pollet1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年6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
124
试验地点
1
主要终点
Oxford Hip Score

研究概览

简要总结

The study aims to understand the existing differences between frail and non-frail subjects who underwent a rehabilitation path after receiving hip or knee arthroplasty surgery.

详细描述

This study wanted to investigate the role of frailty in the rehabilitation path following hip or knee arthroplasty. Subjects will be divided according to the type of arthroplasty received (i.e., hip or knee arthroplasty). Consequently, each arthroplasty group will be divided into a frail group and a non-frail group based on the presence of frailty conditions before receiving surgery. Frailty condition will be assessed using the Primary Care Frailty Index, based on the information reported in each patient's medical record before surgery. Frailty level will be reassessed during the rehabilitation period, specifically at hospitalization in the rehabilitation ward (T0) and Discharge (T1). While other time points considered for the primary outcomes will be at 3-month follow-up (T2) and 1-year follow-up (T3), alongside the primary and secondary outcomes chosen for the study. The different outcomes considered in this study were selected to provide a wide range of information regarding body structure and function, activity level, and perceived level of satisfaction with the intervention. Moreover, the long-term follow-up will collect data on the adverse event rate, which previous studies have shown to significantly impact more frail subjects after receiving arthroplasty. However, the possible protective role of rehabilitation has never been considered. This prospective case-control study is the first to consider the crucial role of rehabilitation in the post-surgical path of subjects receiving arthroplasties. It can serve as a preliminary basis for further trials based on tailored interventions for frail subjects.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • •Received elective hip or knee arthroplasty;
  • •Ability to understand written and oral instructions;
  • •Gave consent to study participation.

排除标准

  • •Arthroplasty revision or not elective intervention;
  • •Participation in other studies;
  • •Hospitalized in the rehabilitation ward more then 10 days after surgery.

结局指标

主要结局

Oxford Hip Score

时间窗: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).

It'a Patient Reported Outcome specific for patients that received Hip Arthroplasty. It investigates the field of autonomy, participation, and pain.

Oxford Knee Score

时间窗: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).

It'a Patient Reported Outcome specific for patients that received Knee Arthroplasty. It investigates the field of autonomy, participation, and pain.

次要结局

  • modified Barthel Index(Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).)
  • Numerical Pain Raitng Scale(Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).)
  • Adverse events(Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).)
  • International Knee Society Rating System(Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).)
  • Merlè D'Aubigne-Postel Scale(Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).)

研究者

发起方
Joel Pollet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Joel Pollet

Principal Investigator

Fondazione Don Carlo Gnocchi Onlus

研究点 (1)

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