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 range
3 Years – 13 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing bioabsorbable nails to titanium nails for my child's forearm fracture — can you explain what the main difference is between these two implants, and why it matters whether one heals faster than the other?
2Since the trial isn't recruiting yet, is there a standard treatment being used right now that would be a good option for my child while we wait to see if this study opens, and would participating later still make sense?
3One of the implants in this trial is bioabsorbable, meaning it dissolves in the body — what are the known risks or unknowns around that type of nail in children compared to the titanium nail that would already be familiar to the surgical team?
4This trial is listed as Phase NA, which I understand may mean it's a device or surgical comparison rather than a drug trial — does that change what we know about safety for both types of nails going in, or are both already considered established options?
5If my child were enrolled and randomized to one nail type rather than the other, would there be any difference in follow-up visits, additional X-rays, or activity restrictions that our family would need to plan around?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.