Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery

Not Applicable

Recruiting

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

• Registration Number: NCT06429267
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

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.

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 Timeline

• Study Start: 2024-02-26
• Status Verified: 2024-05
• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-24
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group (Receiving Metal Screws)	Metal/Titanium Screw	Patients that are randomly assigned to receive traditional, metal screws
Experimental Group (Receiving Bioabsorbable Screws)	Bioabsorbable Screw	Patients that are randomly assigned to receive Bioabsorbable screws

Primary Outcome Measures

Name	Time	Method
Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys	6 weeks, 6 months, 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Complications	1 year	Any complications of surgery (infection etc)

Trial Locations

Locations (1)

Children's Hospital New Orleans; 🇺🇸 New Orleans, Louisiana, United States