Bioabsorbable vs Metal Screws for Broken Bones in Children

Recruiting in Palo Alto (17 mi)

Overseen by Carter Clement, MD, MBA

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Louisiana State University Health Sciences Center in New Orleans

Disqualifiers: Growth plate fractures, Secondary fractures, Non-union, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of bioabsorbable screws for treating broken bones in children?

Bioabsorbable screws, like those made from poly-L-lactide (PLLA) and polyglycolic acid (PGA), have been shown to be effective in treating fractures, with results comparable to metal screws. They offer the advantage of not needing removal surgery, which is beneficial for children as it avoids additional procedures. ^{1 2 3 4 5}

Are bioabsorbable screws safe for use in children?

Bioabsorbable screws, like those made from polylactide (PLLA) and polyglycolic acid (PGA), are generally well-tolerated in children, with no significant inflammation or adverse reactions reported in studies. However, temporary growth retardation was observed in rabbits, and further research is needed to fully understand their long-term safety in children. ^{1 2 3 6 7}

How do bioabsorbable screws differ from metal screws in treating broken bones in children?

Bioabsorbable screws are unique because they gradually dissolve in the body, eliminating the need for a second surgery to remove them, unlike metal screws. They are also compatible with MRI scans and are well tolerated by children, although they may temporarily slow bone growth, which typically recovers over time. ^{1 2 3 4 5}

Research Team

Carter Clement, MD, MBA

Principal Investigator

LSUHSC

Eligibility Criteria

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.

Inclusion Criteria

I need surgery to fix a bone fracture with screws.

Exclusion Criteria

I have had fractures after my initial injury.

Unable or unwilling to provide informed consent or parental/guardian consent for participants under 18 years of age

I have had a tibial tubercle osteotomy.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical fixation using either bioabsorbable or metal screws

Immediate post-surgery

Follow-up

Participants are monitored for bone healing and complications at key intervals

1 year

Visits at 6 weeks, 6 months, and 1 year

Treatment Details

Interventions

• Bioabsorbable Screw (Bioabsorbable)
• Metal/Titanium Screw (Metal)

Trial Overview 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.

Participant Groups

Group I: Experimental Group (Receiving Bioabsorbable Screws) Experimental Treatment 1 Intervention

Patients that are randomly assigned to receive Bioabsorbable screws

Group II: Control Group (Receiving Metal Screws) Active Control 1 Intervention

Patients that are randomly assigned to receive traditional, metal screws

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Hospital New Orleans New Orleans, LA

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

Trials

123

Patients Recruited

42,400+

Findings from Research

In a study of 12 children who underwent pelvic osteotomies using PLGA screws, over 90% of the screw canals were replaced with solid bone within 2 to 4.5 years, indicating effective resorption and bone healing.

While minor reactions such as small bone cysts and fatty patches were observed in some cases, these were not considered clinically significant, suggesting that PLGA screws are safe for use in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI evaluation of resorbable poly lactic-co-glycolic acid (PLGA) screws used in pelvic osteotomies in children-a retrospective case series. Hedelin, H., Hebelka, H., Brisby, H., et al.[2021]

Bioabsorbable screws made of self-reinforced polylevolactic acid (SR-PLLA) demonstrate sufficient biomechanical strength for treating slipped capital femoral epiphysis (SCFE), comparable to traditional steel and titanium screws.

In terms of compression generation, SR-PLLA screws (68.5 N) and steel screws (63.3 N) outperformed titanium screws (3.0 N), indicating their effectiveness in providing necessary fixation during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Biomechanical properties of bioabsorbable cannulated screws for surgical fixation of dislocated epiphysiolysis capitis femoris]. Kröber, MW., Rovinsky, D., Lotz, J., et al.[2019]

Pediatric osteosynthesis has advanced significantly over the past 20 years, leading to reduced hospitalization times and costs associated with treating bone fractures in children.

Biodegradable magnesium-based implants are promising alternatives to traditional titanium implants, as they can eliminate the need for a second surgery to remove implants, thus supporting natural growth in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resorbable implants in pediatric fracture treatment. Grün, NG., Holweg, PL., Donohue, N., et al.[2023]

In a study involving 80 rabbits, various bioabsorbable implants (PGA, PDS, PLLA) and stainless steel pins were tested for their effects on bone healing, showing no significant differences in healing outcomes or biocompatibility between the different materials over a follow-up period of up to 52 weeks.

All implants induced a similar tissue response, with no inflammation observed, and complete degradation of the bioabsorbable materials occurred within 52 weeks, indicating they are safe for use without adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue restoration after implantation of polyglycolide, polydioxanone, polylevolactide, and metallic pins in cortical bone: an experimental study in rabbits. Pihlajamäki, HK., Salminen, ST., Tynninen, O., et al.[2021]

In a study involving 20 lambs, self-reinforced poly-L-lactide (SR-PLLA) miniscrews provided stable fixation for up to 26 weeks without causing significant foreign body reactions or complications, making them a safe option for bone fixation.

Polyglycolide (SR-PGA) miniscrews degraded more quickly, being resorbed by 12 weeks, but this was associated with a transient foreign body reaction and initial osteolysis, suggesting they are suitable for short-term applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SR-PLLA and SR-PGA miniscrews: biodegradation and tissue reactions in the calvarium and dura mater. Peltoniemi, HH., Hallikainen, D., Toivonen, T., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

MRI evaluation of resorbable poly lactic-co-glycolic acid (PLGA) screws used in pelvic osteotomies in children-a retrospective case series. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Transphyseal bioabsorbable screws cause temporary growth retardation in rabbit femur. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Biomechanical properties of bioabsorbable cannulated screws for surgical fixation of dislocated epiphysiolysis capitis femoris]. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Resorbable implants in pediatric fracture treatment. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Absorbable fasteners for the fixation of ankle fractures. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Tissue restoration after implantation of polyglycolide, polydioxanone, polylevolactide, and metallic pins in cortical bone: an experimental study in rabbits. [2021]

7. Scotland pubmed.ncbi.nlm.nih.gov

SR-PLLA and SR-PGA miniscrews: biodegradation and tissue reactions in the calvarium and dura mater. [2022]