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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-13
SponsorChildren's Fractures Interest Group, Denmark

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosis of a traumatic diaphyseal forearm fracture of the radius, ulna, or both

Operative fixation required

Fractures must be complete (not unicortical or greenstick) AND displaced >50% of bone width (after attempted closed reduction) AND/OR angulated >10° in any plane (after attempted closed reduction)

Informed consent obtained

Disqualifiers

Conditions where internal fixation is contraindicated (e.g. active or potential infection)

Grossly open fractures (Gustilo Anderson grade > 2)

Fracture occurred more than 2 weeks prior

Fractures that are well managed conservatively (undisplaced or minimally displaced)

Trial design

Treatments tested in this trial

  • Bioabsorbable intramedullary nail
  • Titanium elastic intramedullary nail

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Fractures Interest Group, Denmark

Lead sponsor

Copenhagen University Hospital at Herlev

Sponsor institution