The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial

Acetabular Fracture Clinical Trial

Official title:

The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298578
• Other study ID #: Mobile Based Application
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Mina Adly Attia
• Phone: +201068385238
• Email: mina.adly2402[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to validate the feasibility of a remote patient monitoring (RPM) system using Mobile App in terms of the frequency of data interruptions and patient acceptance.

The secondary objective is to Improve quality of life and early prediction of the complications.

Description:

Acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation. 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: 126
• Est. completion date: January 1, 2026
• Est. primary completion date: December 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital.

Exclusion Criteria:

• Patients younger than 18years old

Related Conditions & MeSH terms

• Acetabular Fracture
• Fractures, Bone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (14)

Clarke-Jenssen J, Roise O, Storeggen SAO, Madsen JE. Long-term survival and risk factors for failure of the native hip joint after operatively treated displaced acetabular fractures. Bone Joint J. 2017 Jun;99-B(6):834-840. doi: 10.1302/0301-620X.99B6.BJJ-2016-1013.R1. — View Citation

Dodd A, Osterhoff G, Guy P, Lefaivre KA. Assessment of functional outcomes of surgically managed acetabular fractures: a systematic review. Bone Joint J. 2016 May;98-B(5):690-5. doi: 10.1302/0301-620X.98B5.36292. — View Citation

Frietman B, Biert J, Edwards MJR. Patient-reported outcome measures after surgery for an acetabular fracture. Bone Joint J. 2018 May 1;100-B(5):640-645. doi: 10.1302/0301-620X.100B5.BJJ-2017-0871.R3. — View Citation

Giannoudis PV, Grotz MR, Papakostidis C, Dinopoulos H. Operative treatment of displaced fractures of the acetabulum. A meta-analysis. J Bone Joint Surg Br. 2005 Jan;87(1):2-9. — View Citation

Gray RT, Sut MK, Badger SA, Harvey CF. Post-operative telephone review is cost-effective and acceptable to patients. Ulster Med J. 2010 May;79(2):76-9. — View Citation

Hwa K, Wren SM. Telehealth follow-up in lieu of postoperative clinic visit for ambulatory surgery: results of a pilot program. JAMA Surg. 2013 Sep;148(9):823-7. doi: 10.1001/jamasurg.2013.2672. — View Citation

JUDET R, JUDET J, LETOURNEL E. FRACTURES OF THE ACETABULUM: CLASSIFICATION AND SURGICAL APPROACHES FOR OPEN REDUCTION. PRELIMINARY REPORT. J Bone Joint Surg Am. 1964 Dec;46:1615-46. No abstract available. — View Citation

Mears DC, Velyvis JH, Chang CP. Displaced acetabular fractures managed operatively: indicators of outcome. Clin Orthop Relat Res. 2003 Feb;(407):173-86. doi: 10.1097/00003086-200302000-00026. — View Citation

Mishra A, Kapoor L, Mishra SK. Post-operative care through tele-follow up visits in patients undergoing thyroidectomy and parathyroidectomy in a resource-constrained environment. J Telemed Telecare. 2009;15(2):73-6. doi: 10.1258/jtt.2008.080808. — View Citation

Ramkumar PN, Haeberle HS, Ramanathan D, Cantrell WA, Navarro SM, Mont MA, Bloomfield M, Patterson BM. Remote Patient Monitoring Using Mobile Health for Total Knee Arthroplasty: Validation of a Wearable and Machine Learning-Based Surveillance Platform. J Arthroplasty. 2019 Oct;34(10):2253-2259. doi: 10.1016/j.arth.2019.05.021. Epub 2019 May 16. — View Citation

Sanger PC, Hartzler A, Han SM, Armstrong CA, Stewart MR, Lordon RJ, Lober WB, Evans HL. Patient perspectives on post-discharge surgical site infections: towards a patient-centered mobile health solution. PLoS One. 2014 Dec 1;9(12):e114016. doi: 10.1371/journal.pone.0114016. eCollection 2014. — View Citation

Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909. — View Citation

Tannast M, Najibi S, Matta JM. Two to twenty-year survivorship of the hip in 810 patients with operatively treated acetabular fractures. J Bone Joint Surg Am. 2012 Sep 5;94(17):1559-67. doi: 10.2106/JBJS.K.00444. — View Citation

Webb CL, Waugh CL, Grigsby J, Busenbark D, Berdusis K, Sahn DJ, Sable CA; American Society of Echocardiography Telemedicine Collaborators' Group. Impact of telemedicine on hospital transport, length of stay, and medical outcomes in infants with suspected heart disease: a multicenter study. J Am Soc Echocardiogr. 2013 Sep;26(9):1090-8. doi: 10.1016/j.echo.2013.05.018. Epub 2013 Jul 13. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of missed follow up data in both groups postoperatively through assessing the patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum using the Arabic validated form of (SF-36)	Comparison between follow up using mobile app versus in person clinic visit	Baseline
Secondary	Quality of life scoring (Arabic validated form of (SF-36) and early prediction of the complications	Scoring postoperative quality of life and eary detection of complications	Baseline