Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails

Summary

This study looks at children with forearm fractures that need surgery. The standard treatment uses titanium nails, which usually need to be removed in a second operation later. This study compares titanium nails with bioabsorbable nails, which gradually dissolve in the body and may help some children avoid another operation.

The study will compare how quickly the fractures heal on X-ray, and also look at complications, recovery, function, and the family's experience. Children who need surgery will be randomly assigned to one of the two treatments so the comparison is fair.

Hypothesis: The researchers expect that fractures treated with bioabsorbable nails will heal almost as quickly as fractures treated with titanium nails, while reducing the need for later implant removal surgery.

Conditions

• Forearm Injuries
• Radius Fractures
• Ulna Fractures
• Fractures, Bone
• Child
• Adolescent
• Fracture Fixation, Intramedullary
• Internal Fixation
• Orthopedic Operations
• Polymers
• Fracture Healing
• Radiography
• Randomized Controlled Trial (RCT)

Interventions

DEVICE

Bioabsorbable intramedullary nail

Bioabsorbable intramedullary: Surgical fixation of the forearm fracture with a bioabsorbable intramedullary nail made of PLGA (poly\[lactic-co-glycolic acid\]), performed under general anesthesia, followed by above-elbow cast immobilization for 4 weeks. The implant is designed to retain strength during early healing and gradually absorb over time, so routine implant removal is not planned.

DEVICE

Titanium elastic intramedullary nail

Titanium elastic intramedullary nail arm: surgical fixation of the forearm fracture with a titanium elastic intramedullary nail, performed under general anesthesia, followed by above-elbow cast immobilization for 2 weeks. In Denmark, later elective implant removal is standard practice.

Sponsors & Collaborators

• Children's Fractures Interest Group, Denmark

  lead OTHER

Principal Investigators

• Morten J Andersen, MD · Copenhagen University Hospital at Herlev

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2031-05-31

Completion

2031-12-31

Countries

• Denmark

Study Locations