An observational study in Total Hip Arthroplasty, sponsored by Universidad Pontificia Comillas. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by Universidad Pontificia Comillas · Observational
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.
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.
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.
Universidad Pontificia Comillas is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing total hip arthroplasty: Patients were selected who underwent total hip arthroplasty using the same prosthetic design, Furlong Evolution® short stem and ACE acetabular cup. Surgeries were performed at Hospital San Juan de Dios de Santurtzi and Hospital Universitario de Galdakao, both located in Vizcaya.
Exclusion Criteria:
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.
Other: App exercises program
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.
Other: Exercises program
Strength, mobility, and balance exercises described within the standardized Physiotherapy plan.
A strength, mobility, and balance exercise program delivered through a mobile app.
Harris Hip Score (HHS)
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.
Time frame: Evaluation using the HHS is conducted preoperatively, and subsequently at 1 month and 3 months following hip arthroplasty surgery for each participant.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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.
Time frame: Assessment using the WOMAC Index occurs pre-hip arthroplasty surgery, and again at 1 and 3 months post-surgery for each study participant.
Satisfaction Scale
A visual analog scale is used in which the patient simultaneously evaluates their degree of pain and satisfaction, in addition to providing their perception of health status, functional capacity, changes in pain intensity, the impact of arthroplasty on their well-being, and whether their expectations of the surgery have been met
Time frame: Assessment using a visual analog scale at 1 and 3 months post-surgery for each participant in the study.
Plan to share: No
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Universidad Pontificia Comillas