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

NCT06543901 | Completed

• 1 other identifier: MD-321-2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Femur Fracture

Outcome Measures

Primary Outcomes (1)

• Bony union

  we do sequential xrays until we can see a bony union

  6 weeks and 12 weeks

Secondary Outcomes (1)

• Any associated complications

  6 weeks and 12 weeks

Study Arms (2)

Submuscular plate

EXPERIMENTAL

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

Procedure: Submuscular plating

traction with a thomas splint and then casting

ACTIVE COMPARATOR

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

Procedure: Traction and casting

Interventions

Submuscular plating PROCEDURE

the patient was fixed with a submuscular plate

Submuscular plate

Traction and casting PROCEDURE

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

traction with a thomas splint and then casting

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Hospital - Faculty of Medicine - Cairo University

Cairo, 11765, Egypt

Location

MeSH Terms

Conditions

Femoral Fractures

Interventions

Traction

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: This study employs a parallel-group randomized controlled trial (RCT) design. In this model, participants are randomly assigned to one of two groups: the intervention group or the control group. Each participant remains in their assigned group for the duration of the study, receiving either the intervention being tested (MIPO submuscular plate fixation) or the control treatment (conservative management with Thomas splint). This design allows for a direct comparison of the outcomes between the two groups, minimizing bias and ensuring the reliability of the results.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)