Rehabilitation in Total Hip Arthroplasty Through a Mobile Application
NCT ID: NCT06606158
Last Updated: 2024-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2023-07-01
2024-03-30
Brief Summary
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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.
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Detailed Description
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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.
Quality assurance procedures will be implemented to ensure data validity and registry integrity, including data validation checks, source data verification against external sources, and a comprehensive data dictionary detailing each variable\'s origin and coding information.
Standard Operating Procedures (SOPs) will guide registry operations, including patient recruitment, data collection, management, analysis, adverse event reporting, and change management.
A statistical analysis plan will employ appropriate analytical principles and techniques to address primary and secondary objectives outlined in the study protocol, assessing the sample size required to demonstrate significant effects and strategies for handling missing data.
This detailed description encompasses the comprehensive framework and methodology of the study, emphasizing rigorous data collection, quality assurance measures, and statistical analysis strategies essential for evaluating the effectiveness of the mobile application-based follow-up program in post-total hip arthroplasty patients.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1: Non-exposed cohort (mobile application follow-up considered as a protective factor).
Patients who, following hip arthroplasty surgery, were monitored using a mobile application designed to record physical activity data and adherence to a postoperative recovery exercise program. Patients received scheduled instructions regularly within the application, providing educational material and exercise/activity routines, but did not receive formal physical therapy outside of the application as part of the study.
App exercises program
A strength, mobility, and balance exercise program delivered through a mobile app.
Cohort 2: Exposed cohort (no mobile application follow-up).
Patients who, following hip arthroplasty surgery, did not undergo follow-up via the mobile application and followed the standard recovery protocol, which includes regular clinic visits and conventional physiotherapy.
Exercises program
Strength, mobility, and balance exercises described within the standardized Physiotherapy plan.
Interventions
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Exercises program
Strength, mobility, and balance exercises described within the standardized Physiotherapy plan.
App exercises program
A strength, mobility, and balance exercise program delivered through a mobile app.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Universidad Pontificia Comillas
OTHER
Responsible Party
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Joaquín Zambrano Martín
MSc
Principal Investigators
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Joaquín Zambrano-Martín, MSc
Role: PRINCIPAL_INVESTIGATOR
International School of Doctoral Studies, University of Murcia, Murcia, Spain; Comillas Pontifical University, Health Sciences, Department. San Juan de Dios School of Nursing and Physical Therapy, Madrid, Spain
Locations
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International School of Doctoral Studies, University of Murcia
Murcia, , Spain
Countries
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Other Identifiers
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UPC-EIDUM24/25
Identifier Type: -
Identifier Source: org_study_id
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