Total Hip ArthroplastyHIP-AppNCT06606158
Rehabilitation in Total Hip Arthroplasty Through a Mobile Application
An observational study of Total Hip Arthroplasty, run by Universidad Pontificia Comillas at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Exercises program and App exercises program
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2023to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
International School of Doctoral Studies, University of Murcia
Murcia, 30100
About this study
Official title: Rehabilitation in Total Hip Arthroplasty Through a Mobile Application: A Retrospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Exercises program, App exercises program
- Keywords
- Hip Prosthesis, Mobile Applications, Rehabilitation Programs, Digital Health, Patient Reported Outcome Measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises programOther
Strength, mobility, and balance exercises described within the standardized Physiotherapy plan.
App exercises programOther
A strength, mobility, and balance exercise program delivered through a mobile app.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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
Measured: Assessment using a visual analog scale at 1 and 3 months post-surgery for each participant in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Jul 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia Comillas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquín Zambrano Martín, Universidad Pontificia Comillas
- Investigators
- Joaquín Zambrano-Martín, MSc, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606158
- Sponsor's protocol ID
- UPC-EIDUM24/25
- Acronym
- HIP-App
- Status last verified
- Nov 2024
- First submitted
- 15 Jul 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zambrano-Martin J, Moreta J, Gomez-Conesa A, Mendez-Sanchez R, Mendoza-Puente M. Total hip arthroplasty rehabilitation through a mobile application: a retrospective observational study. Hip Int. 2026 Apr 8:11207000261423149. doi: 10.1177/11207000261423149. Online ahead of print.
PubMed 41948908
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation in Total Hip Arthroplasty Through a Mobile Application: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06606158
- Acronym / sponsor ID
- HIP-App / UPC-EIDUM24/25
- Conditions
- Total Hip Arthroplasty
- Keywords
- Hip Prosthesis, Mobile Applications, Rehabilitation Programs, Digital Health, Patient Reported Outcome Measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universidad Pontificia ComillasUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Non-exposed cohort (mobile application follow-up considered as a protective factor). | – | Other: App exercises programPatients 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. |
| Cohort 2: Exposed cohort (no mobile application follow-up). | – | Other: Exercises programPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercises programStrength, mobility, and balance exercises described within the standardized Physiotherapy plan. | Other | Cohort 2: Exposed cohort (no mobile application follow-up). |
| App exercises programA strength, mobility, and balance exercise program delivered through a mobile app. | Other | Cohort 1: Non-exposed cohort (mobile application follow-up considered as a protective factor). |
Primary outcome
Harris Hip Score (HHS)
Time frame: 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)
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.
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.
1 secondary outcome
Satisfaction Scale
Time frame: Assessment using a visual analog scale at 1 and 3 months post-surgery for each participant in the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Derived from this study: PubMed 41948908Zambrano-Martin J, Moreta J, Gomez-Conesa A, Mendez-Sanchez R, Mendoza-Puente M. Total hip arthroplasty rehabilitation through a mobile application: a retrospective observational study. Hip Int. 2026 Apr 8:11207000261423149. doi: 10.1177/11207000261423149. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquín Zambrano-Martín, MSc 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty, run by Universidad Pontificia Comillas at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (HHS) (time frame: Evaluation using the HHS is conducted preoperatively, and subsequently at 1 month and 3 months following hip arthroplasty surgery for each participant.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.