Diaphyseal Femur FractureESIN-THOMASNCT07483944
Comparative Study Between Operative and Non-Operative Management of Femoral Shaft Fractures in Children
A study testing Thomas splint and ESIN (Elastic Stable Intramedullary Nails) in people with Diaphyseal Femur Fracture, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Diaphyseal Femur Fracture
- What is being tested?
- Thomas splint and ESIN (Elastic Stable Intramedullary Nails)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2021to 29 Jun 2024
- Phase
- Interventional
- 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Operative Fixation With Elastic Stable Intramedullary Nails and Non-Operative Thomas Splint Traction in Pediatric Femoral Shaft Fractures
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:
Read more
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.
Read the 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.
- Conditions
- Diaphyseal Femur Fracture
- Being tested
- Thomas splint, ESIN (Elastic Stable Intramedullary Nails)
- Keywords
- Bone nails, femoral fractures, orthotic devices, school age, treatment outcomes
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thomas splintDevice
Thomas splint is type of conservative treatment of different types of long bone fracture mostly lower limbs, it consists of traditional circular ring proximally
ESIN (Elastic Stable Intramedullary Nails)Device
ESIN is used in treatment of most of long bone fractures especially in pediatrics through minimally invasive incisions
| Study group | Role | What they receive |
|---|---|---|
| Thomas splint treatment | Active comparator | Pediatric patients with fracture shaft femur were managed conservatively using Thomas splint, followed by standard post-splint care and follow-up. Receives: Device: Thomas splint |
| Elastic Stable Intramedullary Nail (ESIN) Surgical Treatment. | Experimental | Pediatric patients with fracture shaft femur were managed surgically using ESIN with standard pediatric orthopedic techniques. Receives: Device: ESIN (Elastic Stable Intramedullary Nails) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve fracture bone union radiologically
Time required for fracture healing as confirmed by radiographic evidence of bridging callus across the fracture site on follow-up radiographs.
Measured: From treatment initiation to radiographic union, up to 12 weeks.
Secondary outcomes (5)
Time to achieve full weight bearing
Time from initiation of treatment until the patient is able to bear full weight on the affected limb without assistance.
Measured: From treatment initiation to full weight bearing, up to 12 weeks.
Incidence of complications
Incidence of treatment-related complications such as infection, malunion, limb length discrepancy, or implant-related problems.
Measured: From treatment initiation up to 12 months.
Cost of treatment
Total direct medical cost associated with treatment, including surgical procedure, hospital stay, implants, medications, and other related hospital expenses.
Measured: From treatment initiation to hospital discharge (up to 7 days)
Functional outcome according to Flynn's criteria
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.
Measured: At 6 months,12 months, 2 years and 3 years.
Duration of hospital stay
Number of days the patient remains hospitalized from admission until discharge.
Measured: From admission to discharge (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start3 Jan 2021
- Primary completion29 Jun 2024
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphyseal Femur FractureStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Ibrahim Mohamed Ibrahim, Cairo University
- Investigators
- Hassan Magdy Elbarbary, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483944
- Sponsor's protocol ID
- MD-275-2020
- Acronym
- ESIN-THOMAS
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial including baseline characteristics, intervention details, follow-up data, and primary and secondary outcome measures will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Operative Fixation With Elastic Stable Intramedullary Nails and Non-Operative Thomas Splint Traction in Pediatric Femoral Shaft Fractures
- ClinicalTrials.gov ID
- NCT07483944
- Acronym / sponsor ID
- ESIN-THOMAS / MD-275-2020
- Conditions
- Diaphyseal Femur Fracture
- Keywords
- Bone nails, femoral fractures, orthotic devices, school age, treatment outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 19 Mar 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thomas splint treatment | Active comparator | Device: Thomas splintPediatric patients with fracture shaft femur were managed conservatively using Thomas splint, followed by standard post-splint care and follow-up. |
| Elastic Stable Intramedullary Nail (ESIN) Surgical Treatment. | Experimental | Device: ESIN (Elastic Stable Intramedullary Nails)Pediatric patients with fracture shaft femur were managed surgically using ESIN with standard pediatric orthopedic techniques. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Thomas splintThomas splint is type of conservative treatment of different types of long bone fracture mostly lower limbs, it consists of traditional circular ring proximally | Device | Thomas splint treatment |
| ESIN (Elastic Stable Intramedullary Nails)ESIN is used in treatment of most of long bone fractures especially in pediatrics through minimally invasive incisions | Device | Elastic Stable Intramedullary Nail (ESIN) Surgical Treatment. |
Primary outcome
Time to achieve fracture bone union radiologically
Time frame: 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.
5 secondary outcomes
Time to achieve full weight bearing
Time frame: From treatment initiation to full weight bearing, up to 12 weeks.
Incidence of complications
Time frame: From treatment initiation up to 12 months.
Cost of treatment
Time frame: From treatment initiation to hospital discharge (up to 7 days)
Functional outcome according to Flynn's criteria
Time frame: At 6 months,12 months, 2 years and 3 years.
Duration of hospital stay
Time frame: From admission to discharge (up to 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial including baseline characteristics, intervention details, follow-up data, and primary and secondary outcome measures will be shared.
Related trials for Diaphyseal Femur Fracture
Not yet recruiting
Fixation of Shaft Femure Fracrture by Ender Versus Plate
Shaft Femure Fracture in Adolescents
Not yet recruiting
Pediatric Femur Fractures: Functional Bracing vs Spica Casting - Outcomes and Cost Analysis
Pediatric Femur Fracture
RecruitingObservational study
Study of Residuals Deformities After Diaphyseal Femoral Fracture in Children Treated by Skin Traction
EOS
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.
Hassan Magdy Elbarbary, MD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thomas splint and ESIN (Elastic Stable Intramedullary Nails) in people with Diaphyseal Femur Fracture, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve fracture bone union radiologically (time frame: From treatment initiation to radiographic union, up to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2026.