Recruiting

Bioabsorbable Screws

Sponsor:

Louisiana State University Health Sciences Center in New Orleans

Code:

NCT06429267

Conditions

Pediatric

Fracture

Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures)

Patient Satisfaction

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

Bioabsorbable Screw

Metal/Titanium Screw

Study Details

Brief summary:

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

Pediatric

Fracture

Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures)

Patient Satisfaction

Study ID

NCT06429267

Start date

Feb 26, 2024

Status verified date

May, 2024

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control Group (Receiving Metal Screws)

Patients that are randomly assigned to receive traditional, metal screws

experimental: Experimental Group (Receiving Bioabsorbable Screws)

Patients that are randomly assigned to receive Bioabsorbable screws

Interventions

Bioabsorbable Screw

Bioabsorbable screw that redissolves into the bone. Mineral fibers are composed of Silicon Dioxide (SiO2), Sodium Oxide, Calcium Oxide, Magnesium Oxide, Boron Trioxide, and Phosphorous Pentoxide

Metal/Titanium Screw

Traditional metal screw used in fracture fixation that requires hardware removal

Primary outcome measure

  • Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys [ Time Frame: 6 weeks, 6 months, 1 year ]

Central Contacts and Locations

Central contacts

Sylvia Culpepper, MS

2283270278sculpe@lsuhsc.edu

Carter Clement, MD, MBA

(504) 896-9569

Locations

Children's Hospital New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Sylvia Culpepper, MS

228-327-0278sculpe@lsuhsc.edu

Principal Investigator:

Carter Clement, MD, MBA

More Information

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Last update posted

May 24, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center in New Orleans on 2024-05-24.