Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Co… (NCT07536581) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails
Denmark60 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range3 Years – 13 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* Previous ipsilateral forearm fracture (risk of closed medullary canal)
* Fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal)
* Concurrent ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants)
* Unable to participate in follow-up
* Existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease)
* Participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the PI the results of the present study
Intraoperative exclusion criteria:
* Fractures suitable for closed reduction and casting (see 6.3.9)
* Indication for treatment 1 (BIN) only
* Indication for treatment 2 (ESIN) only
* Intraoperative decision to use implants other than the devices under investigation
What they're measuring
1
Time to fracture healing (weeks)
Timeframe: Postoperative radiographic assessments at 2, 4, and 6 weeks; if healing has not yet been established, additional radiographic assessments at 8 and 10 weeks, until the healing threshold is reached.