Patient Satisfaction Clinical Trial
Official title:
Comprehensive Investigation of Bioabsorbable Screws in Pediatric Orthopedic Surgery: Mechanical Properties, Long-term Performance, and Practical Applications
NCT number | NCT06429267 |
Other study ID # | 6360 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 26, 2024 |
Est. completion date | April 2026 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital New Orleans | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Louisiana State University Health Sciences Center in New Orleans |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys | Pain, Upper Extremity and Mobility. These questionnaires are scored using T scores. For pain, a higher score is a worse outcome. For mobility and upper extremity, a lower score is a worse outcome. Min value is 0 and max is 100 for all. | 6 weeks, 6 months, 1 year | |
Secondary | Complications | Any complications of surgery (infection etc) | 1 year |
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