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Bioabsorbable

Bioabsorbable vs Metal Screws for Broken Bones in Children

N/A
Recruiting
Led By Carter Clement, MD, MBA
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary fractures requiring fixation with cannulated screws
Be younger than 65 years old
Must not have
Secondary fractures
Children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two types of screws used in pediatric surgeries - bioabsorbable screws and metal screws. The study will look at how well bones heal with each type of screw over 6 weeks

Who is the study for?
This trial is for children and teenagers (0 to 18 years old) who need surgery for fixing broken bones. They must be eligible for either bioabsorbable or metal screw placement. A parent or guardian's consent is required since the patients are minors.
What is being tested?
The study compares bioabsorbable screws with conventional metal screws in bone healing after orthopedic surgeries in kids. It checks if the new type of screw can avoid extra surgeries without increasing complications, over periods of 6 weeks, 6 months, and a year.
What are the potential side effects?
Potential side effects may include issues related to the surgical site such as infection, inflammation, pain at the implant area, allergic reactions to materials used in screws, and possible complications leading to additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need surgery to fix a bone fracture with screws.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had fractures after my initial injury.
Select...
My child is 10 or younger and needs surgery with screws for a broken bone.
Select...
I have had a tibial tubercle osteotomy.
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My broken bone hasn't healed properly.
Select...
I have been diagnosed with SCFE.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys
Secondary study objectives
Complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group (Receiving Bioabsorbable Screws)Experimental Treatment1 Intervention
Patients that are randomly assigned to receive Bioabsorbable screws
Group II: Control Group (Receiving Metal Screws)Active Control1 Intervention
Patients that are randomly assigned to receive traditional, metal screws

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansLead Sponsor
120 Previous Clinical Trials
42,807 Total Patients Enrolled
Carter Clement, MD, MBAPrincipal InvestigatorLSUHSC
~38 spots leftby Apr 2026
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