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.

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.

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.

All IPD collected throughout the trial including baseline characteristics, intervention details, follow-up data, and primary and secondary outcome measures will be shared.