Bioabsorbable vs Metal Screws for Broken Bones in Children

Overseen By Carter Clement, MD, MBA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Louisiana State University Health Sciences Center in New Orleans

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Immediate post-surgery

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of screws used in surgeries for children with broken bones: metal screws and bioabsorbable screws, which dissolve over time. The researchers aim to determine if bioabsorbable screws heal bones as effectively as metal screws, with fewer follow-up surgeries. Children with a primary fracture needing screws, without complications like fractures across growth plates or allergies to screw materials, might be suitable candidates. After a parent or guardian provides consent, participants will randomly receive either metal or bioabsorbable screws. As an unphased trial, this study offers a unique opportunity to advance pediatric fracture treatment.

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 prior data suggests that these screws are safe for children?

Research has shown that bioabsorbable screws are increasingly used in children's bone surgeries. Made from materials that the body can absorb over time, these screws do not remain in the body permanently. Studies have found them safe for young patients. Children who received these screws experienced good bone healing and did not require additional surgery for removal, unlike metal screws, which sometimes need removal.

One study examined resorbable magnesium screws in children and found them effective and safe. The children's bones healed well, and the screws dissolved naturally.

Overall, evidence suggests that bioabsorbable screws are safe and well-tolerated in children, offering a promising alternative to metal screws for fixing broken bones. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about bioabsorbable screws for treating broken bones in children because these screws offer a unique advantage over traditional metal screws. Unlike metal screws, which remain in the body and may require a second surgery for removal, bioabsorbable screws gradually dissolve and are absorbed by the body, eliminating the need for additional procedures. This could potentially reduce recovery time and decrease the risk of complications associated with metal implants. Plus, bioabsorbable screws are designed to integrate with the body's natural healing processes, potentially enhancing bone healing and reducing long-term discomfort.

What evidence suggests that this trial's treatments could be effective for bone healing in children?

This trial will compare bioabsorbable screws with metal screws for healing broken bones in children. Research has shown that bioabsorbable screws, which the experimental group will receive, hold promise for healing broken bones in children. Made from materials that break down in the body, these screws can effectively heal fractures and are absorbed over time, potentially reducing the need for additional surgeries. Patients using bioabsorbable screws have experienced good bone healing, and the body accepts them without issues. Meanwhile, the control group will receive traditional metal screws, which work well but may require a second surgery for removal. ^{1 5 6 7 8}

Who Is on the Research Team?

Carter Clement, MD, MBA

Principal Investigator

LSUHSC

Are You a Good Fit for This Trial?

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.

Allergies or contraindications to screw materials

I have had a tibial tubercle osteotomy.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Bioabsorbable Screw
• Metal/Titanium Screw

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.

How Is the Trial Designed?

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

Bioabsorbable Screw is already approved in United States, European Union for the following indications:

Approved in United States as Bioabsorbable Screw for:

• Pediatric orthopedic fractures
• Trauma or elective procedures in children

Approved in European Union as Bioabsorbable Implant for:

• Orthopedic and trauma surgery in children
• Fractures requiring internal osteosynthesis

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

Trials

123

Recruited

42,400+

Published Research Related to This Trial

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 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]

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]

Bioabsorbable materials, such as polyglycolide and poly-L-lactide, used in treating 30 ankle fractures showed results comparable to traditional metal screws, indicating their efficacy in fracture fixation.

The use of bioabsorbable implants eliminates the need for a second surgery to remove hardware, and newer self-reinforced poly-L-lactate screws further reduce the incidence of adverse reactions around the screw heads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absorbable fasteners for the fixation of ankle fractures. George, K., Becker, D., Seligson, D.[2016]

The study involved 24 immature rabbits and demonstrated that the self-reinforced bioabsorbable SR-PLGA 80/20 screw caused temporary growth retardation of the femur for up to 6 weeks post-surgery, with a mean shortening of 11.1 mm at that time.

After 6 weeks, normal growth resumed, indicating that while the screw can effectively stabilize bone during healing, its use may lead to temporary growth issues that need to be carefully considered in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transphyseal bioabsorbable screws cause temporary growth retardation in rabbit femur. Waris, E., Ashammakhi, N., Kelly, CP., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39183229/

Comparison of surgical outcomes between bioabsorbable ... This study aimed to compare the surgical outcomes between bioabsorbable and metal screw fixation for distal tibial physeal fracture in children and adolescents.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2452199X25001409

shifting from absorbable polymers to biodegradable metals We found that the applications of absorbable implants in pediatric orthopedics are shifting from absorbable polymers to biodegradable metals.

3. preprints.org preprints.org/frontend/manuscript/c4183b19738069d55eb4c35f4a3ed717/download_pub

Biodegradable (PLGA) Implants in Pediatric Trauma Early clinical use of magnesium screws in children has shown good biocompatibility and fracture healing with complete implant resorption over ...

4. researchgate.net researchgate.net/publication/389903245_Exploring_the_Efficacy_of_Bio_Resorbable_Plating_in_Paediatric_Maxillofacial_Trauma_A_Literature_Review

(PDF) Exploring the Efficacy of Bio Resorbable Plating in ... Abstract. Background: This systematic review evaluates the effectiveness of bioresorbable plating systems in pediatric maxillofacial trauma.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06429267

Investigation Of Bioabsorbable Screws In Pediatric ... This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8223084/

Use of resorbable magnesium screws in children The aim of this study is to analyze the safety and efficacy of resorbable Mg screw in different orthopaedic procedures in skeletally immature patients.

7. researchgate.net researchgate.net/publication/270366028_Bioresorbable_Plates_and_Screws_for_Clinical_Applications_A_Review

Bioresorbable Plates and Screws for Clinical Applications Bioresorbable implants are being widely used for fracture fixation in orthopaedic surgery and the market is expanding rapidly worldwide.

8. preprints.org preprints.org/manuscript/202511.0107/v1/download

Biodegradable (PLGA) Implants in Pediatric Trauma Early clinical use of magnesium screws in children has shown good biocompatibility and fracture healing with complete implant resorption over ...