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临床试验/NCT06606158
NCT06606158已完成不适用

Rehabilitation in Total Hip Arthroplasty Through a Mobile Application: A Retrospective Observational Study

Universidad Pontificia Comillas1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Harris Hip Score (HHS)

研究概览

简要总结

This observational retrospective study aims to assess the rehabilitation outcomes of patients who underwent total hip arthroplasty (THA) and were monitored through a mobile application versus those who were not. The hypothesis is that patients who receive postoperative follow-up via a mobile app, which includes a recovery exercise program, will experience significantly greater improvements in functionality, quality of life, and treatment adherence compared to those who do not use the app after three months of follow-up.

The study will analyze the records of patients from two cohorts: one group monitored with the mobile application and another group receiving standard postoperative care without the app. Data on patients' functionality, quality of life, and adherence to treatment will be collected and compared between the two groups. This study seeks to provide evidence on the effectiveness of digital health interventions in enhancing postoperative recovery for THA patients.

详细描述

This study adopts an observational, analytical, longitudinal, and retrospective design with two cohorts: an exposed cohort and a non-exposed cohort, aimed at evaluating the effectiveness of a follow-up program using a mobile application in patients undergoing total hip arthroplasty.

Patients selected for this study have undergone total hip arthroplasty using the Furlong Evolution® short stem and acetabular cup prosthetic design (ACE). Surgeries were performed at Hospital San Juan de Dios de Santurtzi and Hospital Universitario de Galdakao, both located in Vizcaya.

To analyze the new care model (functional recovery program and patient follow-up via a digital application), the entire study population from June 1, 2023, to March 30, 2024, will be included, conducting a complete cohort analysis with a 3-month follow-up period.

Data collection includes sociodemographic, clinical, and pre-surgical functional characteristics. Specific assessment tests were employed to evaluate pain, function, and quality of life.

Electronic health records will be used to collect data, including demographic variables (age, gender), medical history, Patient-Reported Outcome Measures (PROMs) such as the Harris Hip Score and WOMAC scale and Patient-Reported-Experience-Mesures (PREMs) as satisfaction scale.

研究设计

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

入排标准

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

入选标准

  • Patients over 18 years old operated at Hospital San Juan de Dios de Santurtzi and Hospital Universitario de Galdakao, both located in Vizcaya.
  • Operated on for total hip arthroplasty with the Furlong Evolution short stem prosthetic design and ACE acetabular cup.
  • Patients who have started postoperative rehabilitation program with or without the mobile application.
  • Ability to walk before the fracture with or without the aid of instruments or persons.
  • Access to a smartphone with the ability to install applications.
  • Patients with complete PROMs data using the Harris Hip Score and WOMAC scale available.

排除标准

  • Patients with incomplete data or lack of follow-up at three months.
  • Patients with severe comorbidities that may significantly affect mobility and functionality.
  • Patients with cognitive impairment that precludes the use of the mobile application for recovery.

结局指标

主要结局

Harris Hip Score (HHS)

时间窗: Evaluation using the HHS is conducted preoperatively, and subsequently at 1 month and 3 months following hip arthroplasty surgery for each participant.

The HHS is a widely used metric to evaluate functional status and hip-related quality of life in patients undergoing total hip arthroplasty. It measures functional capacity based on pain, gait, mobility, and ability to perform daily activities.

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

时间窗: Assessment using the WOMAC Index occurs pre-hip arthroplasty surgery, and again at 1 and 3 months post-surgery for each study participant.

The WOMAC Index is a validated measure assessing pain, stiffness, and physical function in hip osteoarthritis patients. It provides a detailed evaluation of functional disability and impact on hip-related quality of life.

次要结局

  • Satisfaction Scale(Assessment using a visual analog scale at 1 and 3 months post-surgery for each participant in the study.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joaquín Zambrano Martín

MSc

Universidad Pontificia Comillas

研究点 (1)

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