The Utility of Mobile Based Patient Reported Outcome Measures in Patients With Acetabular Fractures: A Randomized Controlled Trial.

Acetabular Fracture Clinical Trial

Official title:

The Utility of Mobile Based Patient Reported Outcome Measures(PROMS) in Patients With Acetabular Fractures: A Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04393571
• Other study ID #: TUOMBPROMSIPWAFARCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation.

Description:

The percentage of patients with lost follow up is significantly high. Previously all other studies mainly focused on the radiographic outcome after acetabular fractures and rarely on patient reported functional outcomes and quality of life. The use of patient-reported outcome measures (PROMs) is increasing and may lead to modifications of treatment. Recent technologic advances, namely smartphones, capable of measuring outcomes after acetabular fractures are now very important in quantifying value-based care. This was previously accomplished through office assessments and surveys with variable follow-up but this strategy lacks continuous and complete data. Studies show that these remote modes of follow-up are safe and that patients are as equally satisfied with them as they are with in-person follow- up care

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients older than 18 years old who will have surgery for an acetabular fracture at assiut university hospitals from 1/10/2020 to 30/9/2022.

Exclusion Criteria:

• patients younger than 18 years.

Related Conditions & MeSH terms

• Acetabular Fracture
• Fractures, Bone
• Mobile Phone Use
• PROMs

Intervention

Other:
• Mobile application
telemedicine is used to overcome distance when patients must travel to receive specialized care. We depend on the available, widely used smartphones via a mobile application to conduct follow up data as regard to patient quality of life and comparing this to conventional follow up visits and whether it help to obtain a complete follow up data

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	AO Trauma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of missed follow up data in both groups at 12 months postoperatively	through assessing the patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum in assiut university hospital using the Arabic validated form of the 36-Item Short Form Health Survey (SF-36).	at least one year follow up
Secondary	the ability of the mobile application to rapidly detect the occurrence of serious postoperative complication.	to record the ability of the mobile application to rapidly detect the occurrence of serious postoperative complication as infection and DVT and notify us by this complication by means of the Red Flag signs which will be added to the application.	at least one year follow up