Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patient Satisfaction; Fracture; Pediatric; Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures)
• Intervention / Treatment: Device: Metal/Titanium Screw; Device: Bioabsorbable Screw

Detailed Description

This study is a prospective randomized controlled trial to evaluate clinical outcomes associated with the use of bioabsorbable screws compared to conventional metal screws in children aged 0 to 18 who are undergoing surgical fixation in the setting of trauma such as medial epicondyle fractures of the elbow or elective procedures. The research will be conducted within the pediatric orthopedic department at CHNOLA, and participants will be assessed at key intervals, including 6 weeks, 6 months, and 1 year post-operation post-operation. The primary objective of this study is to assess and compare the effectiveness of conventional metal screws and bioabsorbable screws in bone healing. This study aims to determine whether bioabsorbable screws are significantly superior to conventional titanium screws. The investigators hypothesize bioabsorbable screws are significantly noninferior to conventional metal screws in terms of complications based on prior surgical constructs that demonstrate bioabsorbable screws eliminate the need for a second surgery After informed consent has been obtained from the parents of patients, eligible patients undergoing cannulated screw fixation will be randomized into two groups: one group who will receive bioabsorbable screws and the other group who will receive metal screws (titanium or stainless steel).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvia Culpepper, MS; Phone Number: 2283270278; Email: sculpe@lsuhsc.edu
• Study Contact Backup: Name: Carter Clement, MD, MBA; Phone Number: (504) 896-9569

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Recruiting
      • Children's Hospital New Orleans
      • Contact: Sylvia Culpepper, MS; Phone Number: 228-327-0278; Email: sculpe@lsuhsc.edu
      • Principal Investigator: Carter Clement, MD, MBA
      • Sub-Investigator: Sylvia Culpepper, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group (Receiving Metal Screws); Patients that are randomly assigned to receive traditional, metal screws	Device: Metal/Titanium Screw; Traditional metal screw used in fracture fixation that requires hardware removal; Other Names: OrthoPediatrics
Experimental: Experimental Group (Receiving Bioabsorbable Screws); Patients that are randomly assigned to receive Bioabsorbable screws	Device: 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; Other Names: Ossiofiber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Any complications of surgery (infection etc)	1 year

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Carter Clement, MD, MBA, LSUHSC

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 6360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes