NCT06298578

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

March 1, 2024

Last Update Submit

March 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of life scoring (Arabic validated form of (SF-36) and early prediction of the complications

    Baseline

Study Arms (2)

In person follow up

mobile app follow up

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Patients younger than 18years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 14239854BACKGROUND
  • 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.

    PMID: 12567145BACKGROUND
  • 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.

    PMID: 29701094BACKGROUND
  • 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.

    PMID: 15686228BACKGROUND
  • 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.

    PMID: 22992846BACKGROUND
  • 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.

    PMID: 28566406BACKGROUND
  • 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.

    PMID: 27143743BACKGROUND
  • 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.

    PMID: 31128890BACKGROUND
  • 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.

    PMID: 25436912BACKGROUND
  • 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.

    PMID: 23860093BACKGROUND
  • 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.

    PMID: 23842982BACKGROUND
  • 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.

    PMID: 19246606BACKGROUND
  • 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.

    PMID: 22356799BACKGROUND
  • 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.

    PMID: 21116423BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 7, 2024

Study Start

April 1, 2024

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

March 7, 2024

Record last verified: 2024-03