Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543901
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Comparative Study Between MIPOSubmuscular Plate Fixation of Fracture Femur and Conservative Management With Thomas Splint in Children From 5 to 8 Years Old A Randomized Clinical Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Study Between MIPOSubmuscular Plate Fixation of Fracture Femur and Conservative Management With Thomas Splint in Children From 5 to 8 Years Old A Randomized Clinical Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None