RECRUITING

Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comprehensive Investigation of Bioabsorbable Screws in Pediatric Orthopedic Surgery: Mechanical Properties, Long-term Performance, and Practical Applications

Quick Facts

Study Start:2024-02-26
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06429267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary fractures requiring fixation with cannulated screws
  1. * Children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis)
  2. * Secondary fractures
  3. * Non-union fractures
  4. * Tibial tubercle osteotomies (TTOs)
  5. * Slipped capital femoral epiphysis (SCFEs)
  6. * Unable or unwilling to provide informed consent or parental/guardian consent for participants under 18 years of age
  7. * Allergies or contraindications to screw materials

Contacts and Locations

Study Contact

Sylvia Culpepper, MS
CONTACT
2283270278
sculpe@lsuhsc.edu
Carter Clement, MD, MBA
CONTACT
(504) 896-9569

Principal Investigator

Carter Clement, MD, MBA
PRINCIPAL_INVESTIGATOR
LSUHSC

Study Locations (Sites)

Children's Hospital New Orleans
New Orleans, Louisiana, 70118
United States

Collaborators and Investigators

Sponsor: Louisiana State University Health Sciences Center in New Orleans

  • Carter Clement, MD, MBA, PRINCIPAL_INVESTIGATOR, LSUHSC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-26
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-02-26
Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

  • Pediatric
  • Fracture
  • Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures)
  • Patient Satisfaction