Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery

Launched by LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER IN NEW ORLEANS · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two types of screws used in surgery for children who have broken bones: bioabsorbable screws, which dissolve in the body over time, and traditional metal screws. The goal is to see if the bioabsorbable screws help bones heal just as well as the metal ones, and whether they can reduce the need for extra surgeries later on. The study is being conducted at Children's Hospital New Orleans and includes children from birth to 18 years old who need screws to fix their fractures.

To participate, children must have a primary fracture that needs screws for treatment, but younger children who have specific conditions or fractures won't be eligible. If a child joins the study, they will be randomly assigned to receive either the bioabsorbable or metal screws after getting permission from a parent or guardian. Throughout the study, the medical team will check how well the bones heal at different times, such as 6 weeks, 6 months, and 1 year after surgery. This research could help improve the way doctors treat broken bones in kids.

Gender

ALL

Eligibility 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