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Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Summary
This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.
Official title: Comprehensive Investigation of Bioabsorbable Screws in Pediatric Orthopedic Surgery: Mechanical Properties, Long-term Performance, and Practical Applications
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-02-26
Completion Date
2026-04
Last Updated
2024-05-24
Healthy Volunteers
Yes
Conditions
Interventions
Bioabsorbable Screw
Bioabsorbable screw that redissolves into the bone. Mineral fibers are composed of Silicon Dioxide (SiO2), Sodium Oxide, Calcium Oxide, Magnesium Oxide, Boron Trioxide, and Phosphorous Pentoxide
Metal/Titanium Screw
Traditional metal screw used in fracture fixation that requires hardware removal
Locations (1)
Children's Hospital New Orleans
New Orleans, Louisiana, United States