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

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.

Study Overview

• Status: Completed
• Conditions: Femur Fracture
• Intervention / Treatment: Procedure: Submuscular plating; Procedure: Traction and casting

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11765
    • Kasr Alainy Hospital - Faculty of Medicine - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Submuscular plate; The patient underwent open reduction and internal fixation by being fixed with a submuscular plate	Procedure: Submuscular plating; the patient was fixed with a submuscular plate
Active Comparator: traction with a thomas splint and then casting; the patient was placed on traction with a thomas splint and then was casted in a spica cast	Procedure: Traction and casting; the patient was placed on a traction with a thomas splint and then was casted with a hip spica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bony union	we do sequential xrays until we can see a bony union	6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any associated complications	such as pain, infection or failure of reduction	6 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: MD-321-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No