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Not yet recruitingNCT06591585Updated Sep 19, 2024

Midterm Follow up of Pediatric Pelvic Fracture Management at Assiut University Hospital

An observational study in Fracture Healing, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
65
Ages
Up to 17 Years
Sex
All
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Study 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 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

02

Conditions studied

  • Fracture Healing

Keywords

  • pediatric pelvic fracture
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In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 65 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with age ≤17years with Open fracture\ Closed fractures pelvis that was treated surgically or not

Inclusion criteria

  1. patient age ≤17years
  2. Open fracture\ Closed fractures
  3. with or without neurovascular injury
  4. polytrauma (including femur \& tibia fracture)
  5. patients who were treated conservatively (bed rest + traction)
  6. patients treated surgically

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
65 participants (estimated)
Patient registry
No

Interventions

  • RadiationFracture Healing

    A-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

06

What researchers measure

Primary outcomes

  1. Modified Majeed Functional scoring system

    Time frame: base line

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06591585
Lead sponsor
Assiut University
Responsible party
Kirollos Raafat Ramzy Wahba (doctor, Assiut University) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 2024 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

kirollos raafat Ramzy, Physician
Contact
Cerles.14223850@med.aun.edu.eg
0882063123

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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