Actively Recruiting
Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery
Led by Louisiana State University Health Sciences Center in New Orleans · Updated on 2024-05-24
60
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary fractures requiring fixation with cannulated screws
You will not qualify if you...
- Children ten years old or under with a fracture requiring screws 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
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Trial Site Locations
Total: 1 location
1
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
Research Team
S
Sylvia Culpepper, MS
CONTACT
C
Carter Clement, MD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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