Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control Group (Receiving Metal Screws)

Patients that are randomly assigned to receive traditional, metal screws

Group Type ACTIVE_COMPARATOR

Metal/Titanium Screw

Intervention Type DEVICE

Traditional metal screw used in fracture fixation that requires hardware removal

Experimental Group (Receiving Bioabsorbable Screws)

Patients that are randomly assigned to receive Bioabsorbable screws

Group Type EXPERIMENTAL

Bioabsorbable Screw

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Metal/Titanium Screw

Traditional metal screw used in fracture fixation that requires hardware removal

Intervention Type DEVICE

Other Intervention Names

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Ossiofiber OrthoPediatrics

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes