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
NCT ID: NCT06543901
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-01-01
2023-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Submuscular plate
The patient underwent open reduction and internal fixation by being fixed with a submuscular plate
Submuscular plating
the patient was fixed with a submuscular plate
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
Traction and casting
the patient was placed on a traction with a thomas splint and then was casted with a hip spica
Interventions
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Submuscular plating
the patient was fixed with a submuscular plate
Traction and casting
the patient was placed on a traction with a thomas splint and then was casted with a hip spica
Eligibility Criteria
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Inclusion Criteria
2. Patients with midshaft or distal shaft femur fracture.
3. Fracture pattern: transverse - oblique - spiral.
4. Children must be \< 45 KG.
Exclusion Criteria
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.
5 Years
8 Years
ALL
No
Sponsors
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Kasr El Aini Hospital
OTHER
Responsible Party
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Ahmed Omar Sabry
Dr.
Locations
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Kasr Alainy Hospital - Faculty of Medicine - Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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MD-321-2021
Identifier Type: -
Identifier Source: org_study_id
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