Clinical trial NCT06543901: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femur Fracture
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bony union
timeFrame: 6 weeks and 12 weeks
Secondary outcomes:
measure: Any associated complications
timeFrame: 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy Hospital - Faculty of Medicine - Cairo University
Study officials:
References: