NCT06606158

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

July 15, 2024

Last Update Submit

November 11, 2024

Conditions

Keywords

Hip ProsthesisMobile ApplicationsRehabilitation ProgramsDigital HealthPatient Reported Outcome Measures

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Secondary Outcomes (1)

  • Satisfaction Scale

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

Study Arms (2)

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.

Other: App exercises program

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.

Other: Exercises program

Interventions

Strength, mobility, and balance exercises described within the standardized Physiotherapy plan.

Cohort 2: Exposed cohort (no mobile application follow-up).

A strength, mobility, and balance exercise program delivered through a mobile app.

Cohort 1: Non-exposed cohort (mobile application follow-up considered as a protective factor).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International School of Doctoral Studies, University of Murcia

Murcia, 30100, Spain

Location

Study Officials

  • Joaquín Zambrano-Martín, MSc

    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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

July 15, 2024

First Posted

September 20, 2024

Study Start

July 1, 2023

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations