Comparative Study Between (MIPO)Submuscular Plate Fixation of Fracture Femur and Conservative Management With Thomas Splint in Children From 5 to 8 Years Old: A Randomized Clinical Study

Kasr El Aini Hospital

Status: Completed

Conditions: Femur Fracture

Treatments: Procedure: Traction and casting; Procedure: Submuscular plating

Study type: Interventional

Funder types: Other

Identifiers

NCT06543901

MD-321-2021

Details and patient eligibility

About

This randomized clinical study compares the outcomes of two treatment methods for femur fractures in children aged 5 to 8 years: Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation and conservative management using a Thomas splint. The study evaluates the efficacy, safety, and recovery outcomes of both techniques. Key parameters include healing time, functional outcomes, complication rates, and patient and caregiver satisfaction. The findings aim to provide evidence-based recommendations for the optimal management of femur fractures in young children, balancing the benefits and risks of surgical versus non-surgical approaches.

Full description

Introduction:

Femur fractures are common pediatric injuries that require effective treatment to ensure proper healing and prevent long-term complications. While conservative management with a Thomas splint is a traditional method, Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation has gained popularity due to its potential for faster recovery and reduced complications. This study aims to compare the outcomes of these two treatment modalities in children aged 5 to 8 years.

Objectives:

To compare the healing time between MIPO submuscular plate fixation and conservative management with Thomas splint.

To assess the functional outcomes of both treatment methods. To evaluate the complication rates associated with each treatment. To measure patient and caregiver satisfaction with each treatment approach.

Methods:

Study Design: Randomized clinical study. Participants: Children aged 5 to 8 years with femur fractures, meeting specific inclusion and exclusion criteria.

Randomization: Participants will be randomly assigned to either the MIPO submuscular plate fixation group or the conservative management with Thomas splint group.

Interventions:

MIPO Group: Surgical intervention using minimally invasive techniques to place a submuscular plate for fracture fixation.

Thomas Splint Group: Conservative management using a Thomas splint for immobilization and fracture healing.

Follow-Up: Regular follow-up visits at specified intervals to monitor healing, assess functional outcomes, and record any complications.

Outcome Measures:

Primary Outcome: Healing time, defined as the time from intervention to radiographic evidence of fracture union.

Secondary Outcomes:

Functional outcomes assessed using standardized pediatric orthopedic scoring systems.

Complication rates, including infection, malunion, nonunion, and reoperation rates.

Patient and caregiver satisfaction assessed through questionnaires and interviews.

Enrollment: 40 patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children from 5 to 8 years.
2. Patients with midshaft or distal shaft femur fracture.
3. Fracture pattern: transverse - oblique - spiral.
4. Children must be < 45 KG.

Exclusion criteria

1. Open fracture
2. Any associated fracture in the same limb or in contralateral limb
3. Associated serious internal organ injury or vascular injury
4. Proximal, distal physeal femur fracture.
5. Patient with pathological bone disease as osteogenesis imperfecta.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Submuscular plate

Experimental group

Description:

The patient underwent open reduction and internal fixation by being fixed with a submuscular plate

Treatment:

Procedure: Submuscular plating

traction with a thomas splint and then casting

Active Comparator group

Description:

the patient was placed on traction with a thomas splint and then was casted in a spica cast

Treatment:

Procedure: Traction and casting