Diaphyseal Femur Fracture
Conditions
Keywords
Bone nails, femoral fractures, orthotic devices, school age, treatment outcomes
Brief summary
The goal of this clinical trial was to compare the management of pediatric femoral shaft fractures using either Thomas splint traction or Elastic Stable Intramedullary Nailing (ESIN). The main questions it aimed to answer were: Did ESIN provide faster fracture healing and earlier mobilization compared with Thomas splint traction? Were there differences in complications and functional outcomes between the two treatment methods? Researchers compared ESIN surgical fixation with Thomas splint traction to determine which treatment provided better clinical and functional outcomes in children with femoral shaft fractures. Participants: Were randomly assigned to receive either ESIN surgical fixation or Thomas splint traction. Underwent regular clinical and radiographic follow-up to assess fracture healing, alignment, and recovery. Were evaluated for complications, time to mobilization, functional outcomes, and treatment cost during the follow-up period.
Detailed description
Femoral shaft fractures are among the most common major injuries in the pediatric population. The optimal method of treatment in children between 5 to 16 years remains a subject of ongoing debate, particularly in settings where surgical resources may be limited. Traditionally, conservative treatment using traction and immobilization methods such as the Thomas splint has been widely used. However, surgical fixation with Elastic Stable Intramedullary Nailing (ESIN) has gained popularity because it allows for stable fixation, earlier mobilization, and shorter hospital stay. This randomized clinical trial was conducted at a single center, and the data were registered retrospectively after completion of patient enrollment and follow-up which aimed to compare the clinical and radiological outcomes of Elastic Stable Intramedullary Nailing (ESIN) versus Thomas splint traction in the treatment of pediatric femoral shaft fractures. Eligible pediatric patients presenting with femoral shaft fractures were randomly assigned to one of two treatment groups. The first group was managed conservatively using Thomas splint traction according to standard protocols, while the second group underwent surgical fixation using ESIN. Participants were followed clinically and radiographically at scheduled intervals to assess fracture healing, alignment, time to mobilization, and complications. Functional outcomes and adverse events were also documented and compared between the two groups. The results of this study may help determine whether ESIN offers significant advantages over traditional conservative treatment with the Thomas splint in the management of pediatric femoral shaft fractures, particularly in healthcare settings where resources may vary.
Interventions
DEVICEThomas splint
Thomas splint is type of conservative treatment of different types of long bone fracture mostly lower limbs, it consists of traditional circular ring proximally
DEVICEESIN (Elastic Stable Intramedullary Nails)
ESIN is used in treatment of most of long bone fractures especially in pediatrics through minimally invasive incisions
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomized into two parallel groups to receive either Elastic Stable Intramedullary Nailing (ESIN) or Thomas splint traction for the treatment of pediatric femoral shaft fractures.
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* children aged 5 to 11 years * patients diagnosed with acute, closed and stable femoral shaft fractures (transverse, oblique or spiral patterns) * patients less than 45 kg in body weight. * Written informed consent obtained from parents or legal guardians.
Exclusion criteria
* patients with open or pathological fractures. * patients with unstable (segmental or comminuted) fractures. * patient with proximal or distal physeal involvement. * patients with associated polytrauma, multiple fractures or neurovascular injury requiring urgent surgical intervention. * patients with neuromuscular or cognitive disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve fracture bone union radiologically | From treatment initiation to radiographic union, up to 12 weeks. | Time required for fracture healing as confirmed by radiographic evidence of bridging callus across the fracture site on follow-up radiographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve full weight bearing | From treatment initiation to full weight bearing, up to 12 weeks. | Time from initiation of treatment until the patient is able to bear full weight on the affected limb without assistance. |
| Incidence of complications | From treatment initiation up to 12 months. | Incidence of treatment-related complications such as infection, malunion, limb length discrepancy, or implant-related problems. |
| Cost of treatment | From treatment initiation to hospital discharge (up to 7 days) | Total direct medical cost associated with treatment, including surgical procedure, hospital stay, implants, medications, and other related hospital expenses. |
| Functional outcome according to Flynn's criteria | At 6 months,12 months, 2 years and 3 years. | Clinical outcome assessment based on Flynn's criteria, which evaluates limb length discrepancy, malalignment, pain, and complications. Results are categorized as excellent, satisfactory, or poor. |
| Duration of hospital stay | From admission to discharge (up to 7 days) | Number of days the patient remains hospitalized from admission until discharge. |
Countries
Egypt
Contacts
STUDY_CHAIRHassan Magdy Elbarbary, MD
Cairo University
Outcome results
None listed