Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery

NCT06429267 | Recruiting FDA Device

• 1 other identifier: 6360
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications

  1 year

Study Arms (2)

Control Group (Receiving Metal Screws)

ACTIVE COMPARATOR

Patients that are randomly assigned to receive traditional, metal screws

Device: Metal/Titanium Screw

Experimental Group (Receiving Bioabsorbable Screws)

EXPERIMENTAL

Patients that are randomly assigned to receive Bioabsorbable screws

Device: Bioabsorbable Screw

Interventions

Bioabsorbable Screw DEVICE

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

Also known as: Ossiofiber

Experimental Group (Receiving Bioabsorbable Screws)

Metal/Titanium Screw DEVICE

Traditional metal screw used in fracture fixation that requires hardware removal

Also known as: OrthoPediatrics

Control Group (Receiving Metal Screws)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primary fractures requiring fixation with cannulated screws

You may not qualify if:

• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Patient Satisfaction

Condition Hierarchy (Ancestors)

Wounds and Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Carter Clement, MD, MBA

  LSUHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvia Culpepper, MS

CONTACT

2283270278; sculpe@lsuhsc.edu

Carter Clement, MD, MBA

CONTACT

(504) 896-9569

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two groups which will determine the type of screw (stainless steel or bioabsorbable) in their surgery.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 24, 2024
• Study Start: February 26, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)