Comparing bioabsorbable screws to metal screws in children's orthopedic surgery
Comprehensive Investigation of Bioabsorbable Screws in Pediatric Orthopedic Surgery: Mechanical Properties, Long-term Performance, and Practical Applications
NA · Louisiana State University Health Sciences Center in New Orleans · NCT06429267
This study is testing if using bioabsorbable screws instead of metal screws helps kids heal better after orthopedic surgery and reduces the chances of needing more surgeries later.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Louisiana State University Health Sciences Center in New Orleans (other) |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT06429267 on ClinicalTrials.gov |
What this trial studies
This study is a prospective randomized controlled trial that evaluates the clinical outcomes of bioabsorbable screws versus conventional metal screws in pediatric patients aged 0 to 18 undergoing surgical fixation for fractures or elective procedures. Conducted at Children's Hospital New Orleans, the research aims to assess bone healing effectiveness at intervals of 6 weeks, 6 months, and 1 year post-operation. Participants will be randomly assigned to receive either bioabsorbable or metal screws after obtaining informed consent from a parent or guardian, with the goal of determining if bioabsorbable screws can reduce the need for secondary surgeries due to complications.
Who should consider this trial
Good fit: Ideal candidates are children aged 0 to 18 with primary fractures requiring fixation with cannulated screws.
Not a fit: Patients with fractures involving the growth plate, secondary fractures, or specific conditions like slipped capital femoral epiphysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced need for follow-up surgeries in pediatric orthopedic patients.
How similar studies have performed: Previous studies have shown promising results with bioabsorbable screws, suggesting potential advantages over traditional metal screws, although this specific comparison in pediatric patients is less common.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Orleans, Louisiana
- Children's Hospital New Orleans — New Orleans, Louisiana, United States (RECRUITING)
Study contacts
- Principal investigator: Carter Clement, MD, MBA — LSUHSC
- Study coordinator: Sylvia Culpepper, MS
- Email: sculpe@lsuhsc.edu
- Phone: 2283270278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pediatric, Fracture, Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices, Patient Satisfaction