Acetabular FractureNCT06298578
The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial
An observational study of Acetabular Fracture, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fracture
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Jan 2026
- 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
- Adult, Older adult
Study population: All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital.
Who may be able to join
- All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital.
Who cannot join
- Patients younger than 18years old
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Conditions
- Acetabular Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| In person follow up | Not described | |
| mobile app follow up | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acetabular FractureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adly Attia Ayoub, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298578
- Sponsor's protocol ID
- Mobile Based Application
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 14239854Mears 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.
PubMed 12567145Frietman 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.
PubMed 29701094Giannoudis 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.
PubMed 15686228Tannast 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.
PubMed 22992846Clarke-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.
PubMed 28566406Dodd 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.
PubMed 27143743Ramkumar 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.
PubMed 31128890Sanger 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.
PubMed 25436912Webb 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.
PubMed 23860093Hwa 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.
PubMed 23842982Mishra 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.
PubMed 19246606Seto 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.
PubMed 22356799Gray 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.
PubMed 21116423
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06298578
- Acronym / sponsor ID
- Mobile Based Application
- Conditions
- Acetabular Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 7 Mar 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.
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.
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In person follow up | – | – |
| mobile app follow up | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital.
Key inclusion criteria (1 listed)
- All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital.
Key exclusion criteria (1 listed)
- Patients younger than 18years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Time frame: Baseline
Comparison between follow up using mobile app versus in person clinic visit
1 secondary outcome
Quality of life scoring (Arabic validated form of (SF-36) and early prediction of the complications
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 14239854JUDET 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.
- Background: PubMed 12567145Mears 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.
- Background: PubMed 29701094Frietman 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.
- Background: PubMed 15686228Giannoudis 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.
- Background: PubMed 22992846Tannast 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.
- Background: PubMed 28566406Clarke-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.
- Background: PubMed 27143743Dodd 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.
- Background: PubMed 31128890Ramkumar 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.
- Background: PubMed 25436912Sanger 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.
- Background: PubMed 23860093Webb 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.
- Background: PubMed 23842982Hwa 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.
- Background: PubMed 19246606Mishra 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetabular Fracture, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Adly Attia (+201068385238, mina.adly2402@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Baseline). 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 NCT06298578, which also lists 14 linked publications.
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 7 Mar 2024.