Comprehensive Investigation of Bioabsorbable Screws in Pediatric Orthopedic Surgery: Mechanical Properties, Long-term Performance, and Practical Applications
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.
Description
This study is a prospective randomized controlled trial to evaluate clinical outcomes associated with the use of bioabsorbable screws compared to conventional metal screws in children aged 0 to 18 who are undergoing surgical fixation in the setting of trauma such as medial epicondyle fractures of the elbow or elective procedures. The research will be conducted within the pediatric orthopedic department at CHNOLA, and participants will be assessed at key intervals, including 6 weeks, 6 months, and 1 year post-operation post-operation. The primary objective of this study is to assess and compare…
Eligibility
- Age range
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Primary fractures requiring fixation with cannulated screws Exclusion Criteria: * Children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis) * Secondary fractures * Non-union fractures * Tibial tubercle osteotomies (TTOs) * Slipped capital femoral epiphysis (SCFEs) * Unable or unwilling to provide informed consent or parental/guardian consent for participants under 18 years of age * Allergies or contraindications to screw materials
Interventions
- DeviceBioabsorbable 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
- DeviceMetal/Titanium Screw
Traditional metal screw used in fracture fixation that requires hardware removal
Location
- Children's Hospital New OrleansNew Orleans, Louisiana