Fracture HealingNCT06591585
Midterm Follow up of Pediatric Pelvic Fracture Management at Assiut University Hospital
An observational study of Fracture Healing, run by Assiut University.
Trial summary
Midterm radiographic and function follow up of pediatric pelvic fractures managed at Assiut University Hospital ( AUH) with a minimum of 3 years Analysis of all recorded cases of pediatric Pelvic Fracture in AUH trauma unit from 2015 until june 2024 Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Fracture Healing
- What is being tested?
- Fracture Healing
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Nov 2025
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: patients with age ≤17years with Open fracture\ Closed fractures pelvis that was treated surgically or not
Who may be able to join
- patient age ≤17years
- Open fracture\ Closed fractures
- with or without neurovascular injury
- polytrauma (including femur \& tibia fracture)
- patients who were treated conservatively (bed rest + traction)
- patients treated surgically
Who cannot join
- patients aged \>17 years Isolated acetabulum Fractures Sample size calculation : Sample size was calculated using Epi- Info7. According to results of previous study [4] , Pelvic asymmetry occurs in 9.2% of patients undergoing open reduction internal fixation . Based on this percentage, confidence limits of 5% and a confidence level of 95%, the sample needed for the study was estimated to be about 63 patients
Trial locations and contacts
No sites are listed yet.
About this study
Midterm radiographic and function follow up of pediatric pelvic fractures managed at Assiut University Hospital ( AUH) with a minimum of 3 years Analysis of all recorded cases of pediatric Pelvic Fracture in AUH trauma unit from 2015 until june 2024
Read the detailed description
Pelvic fractures in children as a result of trauma are uncommon and typically follow high-energy trauma [1].
Due to flexible sacroiliac joints (SIJs) and symphysis pubis, the young pediatric skeleton has inherent flexibility, which makes pediatric pelvic fractures (PPFs) different from adult pelvic fractures . Additionally, the cartilaginous cover serves as a shock absorber. [2].
Since the young skeleton can remodel , nonsurgical therapy has been the norm for PPF; nevertheless, this has resulted in a number of long-term problems, such as nonunion, malunion, scoliosis, and pelvic asymmetry. Children with unstable pelvic fractures may experience chronic neurological impairment, low back pain, persistent pain, and limping in up to 30% of cases [2]. Several factors determine whether to treat these fractures surgically or nonsurgically: Initially, the physiological age of the patient AO/OTA classification, divides pelvic fractures into three basic types
. Type A pelvic fractures does not involve the posterior arch (stable), whereas type B results from rotational forces that cause partial posterior complex disruption (rotationally unstable). In type C, there is complete posterior complex disruption (rotationally and vertically unstable).
According to a study established by the German Trauma Society (DGU) and the German Section of the Association for Osteosynthesis /Association for the Study of Internal Fixation (AO/ASIF) International in 1991. The registry provides data on all patients suffering pelvic fractures within a 14-year time frame. They identified a total of 9684 patients including 1433 pelvic fractures in children aged ≤17 years , in pelvic factures of Type A (Tile classification of pelvic fractures), a standard mortality ratio (SMR)( The standardized mortality ratio is the ratio of observed deaths in the study group to expected deaths in the general population) of 0.76 was recorded, in Type B fractures 0.65, and in Type C fractures 0.79. [3].
In our institute, Assiut University Hospital Trauma Unit, pelvic fracture cases were recorded from 2015 until june 2023 , 2041 cases of pelvic fracture were recorded 222 of those cases belong to age group below 17 years so pediatric pelvic fractures represent 10.87% of all recorded pelvic fractures.
The main question in our research proposal according to protocol discussion is what happens after pelvic fracture in pediatric cases as regards to deformities and can remodelling in pediatrics fix these deformities and what is the effect of these deformities on function later on
- Conditions
- Fracture Healing
- Being tested
- Fracture Healing
- Keywords
- pediatric pelvic fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture HealingRadiation
A-Clinical evaluation
- Patients will be recruited for evaluation of documented short / long term complications:
- subcutaneous haematoma
- pin tract infection
- surgical site infection
- limb length discrepancy
- arthritis of the hip and spine
- SI joint pain or fusion
- scoliosis
- Visually assisted gait analysis B- Radiographic evaluation
1-Radiographic evaluation of pelvic integrity by plain X-ray ( Antero-posterior . inlet . outlet views) 2- Long film for limb length discrepancy 3- plain x ray whole spine Anterior -posterior \& lateral for scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Majeed Functional scoring system
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
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 Fracture HealingStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirollos Raafat Ramzy Wahba, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591585
- Sponsor's protocol ID
- MFU pediatric pelvic fracture
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sanz-Esteban I, Calvo-Lobo C, Rios-Lago M, Alvarez-Linera J, Munoz-Garcia D, Rodriguez-Sanz D. Mapping the human brain during a specific Vojta's tactile input: the ipsilateral putamen's role. Medicine (Baltimore). 2018 Mar;97(13):e0253. doi: 10.1097/MD.0000000000010253.
PubMed 29595683
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midterm Follow up of Pediatric Pelvic Fracture Management at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06591585
- Acronym / sponsor ID
- MFU pediatric pelvic fracture
- Conditions
- Fracture Healing
- Keywords
- pediatric pelvic fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 19 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.
Midterm radiographic and function follow up of pediatric pelvic fractures managed at Assiut University Hospital ( AUH) with a minimum of 3 years Analysis of all recorded cases of pediatric Pelvic Fracture in AUH trauma unit from 2015 until june 2024
Detailed description
Pelvic fractures in children as a result of trauma are uncommon and typically follow high-energy trauma [1].
Due to flexible sacroiliac joints (SIJs) and symphysis pubis, the young pediatric skeleton has inherent flexibility, which makes pediatric pelvic fractures (PPFs) different from adult pelvic fractures . Additionally, the cartilaginous cover serves as a shock absorber. [2].
Since the young skeleton can remodel , nonsurgical therapy has been the norm for PPF; nevertheless, this has resulted in a number of long-term problems, such as nonunion, malunion, scoliosis, and pelvic asymmetry. Children with unstable pelvic fractures may experience chronic neurological impairment, low back pain, persistent pain, and limping in up to 30% of cases [2]. Several factors determine whether to treat these fractures surgically or nonsurgically: Initially, the physiological age of the patient AO/OTA classification, divides pelvic fractures into three basic types
. Type A pelvic fractures does not involve the posterior arch (stable), whereas type B results from rotational forces that cause partial posterior complex disruption (rotationally unstable). In type C, there is complete posterior complex disruption (rotationally and vertically unstable).
According to a study established by the German Trauma Society (DGU) and the German Section of the Association for Osteosynthesis /Association for the Study of Internal Fixation (AO/ASIF) International in 1991. The registry provides data on all patients suffering pelvic fractures within a 14-year time frame. They identified a total of 9684 patients including 1433 pelvic fractures in children aged ≤17 years , in pelvic factures of Type A (Tile classification of pelvic fractures), a standard mortality ratio (SMR)( The standardized mortality ratio is the ratio of observed deaths in the study group to expected deaths in the general population) of 0.76 was recorded, in Type B fractures 0.65, and in Type C fractures 0.79. [3].
In our institute, Assiut University Hospital Trauma Unit, pelvic fracture cases were recorded from 2015 until june 2023 , 2041 cases of pelvic fracture were recorded 222 of those cases belong to age group below 17 years so pediatric pelvic fractures represent 10.87% of all recorded pelvic fractures.
The main question in our research proposal according to protocol discussion is what happens after pelvic fracture in pediatric cases as regards to deformities and can remodelling in pediatrics fix these deformities and what is the effect of these deformities on function later on
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients with age ≤17years with Open fracture\ Closed fractures pelvis that was treated surgically or not
Key inclusion criteria (6 listed)
- patient age ≤17years
- Open fracture\ Closed fractures
- with or without neurovascular injury
- polytrauma (including femur \& tibia fracture)
- patients who were treated conservatively (bed rest + traction)
Key exclusion criteria (1 listed)
- patients aged \>17 years Isolated acetabulum Fractures Sample size calculation : Sample size was calculated using Epi- Info7. According to results of previous study [4] , Pelvic asymmetry occurs in 9.2% of patients undergoing open reduction internal fixation . Based on this percentage, confidence limits of 5% and a confidence level of 95%, the sample needed for the study was estimated to be about 63 patients
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 |
|---|---|---|
| Fracture HealingA-Clinical evaluation 1. Patients will be recruited for evaluation of documented short / long term complications: * subcutaneous haematoma * pin tract infection * surgical site infection * limb length discrepancy * arthritis of the hip and spine * SI joint pain or fusion * scoliosis 2. Visually assisted gait analysis B- Radiographic evaluation 1-Radiographic evaluation of pelvic integrity by plain X-ray ( Antero-posterior . inlet . outlet views) 2- Long film for limb length discrepancy 3- plain x ray whole spine Anterior -posterior \& lateral for scoliosis | Radiation | – |
Primary outcome
Modified Majeed Functional scoring system
Time frame: base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 29595683Sanz-Esteban I, Calvo-Lobo C, Rios-Lago M, Alvarez-Linera J, Munoz-Garcia D, Rodriguez-Sanz D. Mapping the human brain during a specific Vojta's tactile input: the ipsilateral putamen's role. Medicine (Baltimore). 2018 Mar;97(13):e0253. doi: 10.1097/MD.0000000000010253.
- Individual participant dataSharing planned: Yes
Related trials for Fracture Healing
Active, not recruiting
Comparison of Functional Results and Complications Between K-Wire Tension Band Fixation and Interosseous Suturing in Transverse Patellar Fractures: A Randomized Controlled Trial
Patella Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingObservational study
Bone Stress Injury Recovery and Return to Sport: A Natural History Study
Bone Stress Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruitingPhase 1/2
PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot)
Lower Extremity Fractures, Pelvis
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 Fracture Healing, 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 6 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 19 Sep 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 kirollos raafat Ramzy, Physician (0882063123, Cerles.14223850@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Majeed Functional scoring system (time frame: base line). 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 NCT06591585, 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 19 Sep 2024.