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Bioabsorbable vs. Metal Screws in Pediatric Fracture Repair

This study is comparing two types of screws used in children (ages 0-18) for fixing fractures: bioabsorbable screws and traditional metal/titanium screws. Bioabsorbable screws are designed to naturally dissolve into the bone over time, potentially avoiding a second surgery to remove them. The study wants to see if these bioabsorbable screws work as well as, or better than, metal screws in helping bones heal and reducing complications. You might be eligible if you have a primary fracture needing screw fixation, but not if you have certain other fracture types or are under 10 with a growth plate fracture. The study will measure how well you recover using surveys at 6 weeks, 6 months, and 1 year after surgery. The current recruitment status is unclear.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to receive either bioabsorbable screws or metal screws. The study plans to enroll 60 participants.
What's involved
If you participate, you will have follow-up assessments using PROMIS surveys at 6 weeks, 6 months, and 1 year after your surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1 year after their surgery, with assessments at 6 weeks, 6 months, and 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06429267

Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery

UNKNOWN
NAUp to 18InterventionalTreatment
Louisiana State University Health Sciences Center in New Orleans
~60 participants
Updated 2024-05-24 on ClinicalTrials.gov
What's tested:Bioabsorbable ScrewMetal/Titanium Screw

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys
Measured over 6 weeks, 6 months, 1 year

Conditions

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

Explore related trials

Fracture

Where it's being run

1 sites across 1 states
Louisiana1

Study leadership

  • Carter Clement, MD, MBA · PRINCIPAL_INVESTIGATOR · LSUHSC

Who to contact

Sylvia Culpepper, MS
[email protected]
2283270278
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Primary fractures requiring fixation with cannulated screws

Exclusion

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

What this trial measures

  • Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys6 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.