An interventional study of Bioabsorbable intramedullary nail and Titanium elastic intramedullary nail in Forearm Injuries, Radius Fractures and Ulna Fractures, sponsored by Children's Fractures Interest Group, Denmark. Not yet recruiting at 1 site in Denmark. Open to participants aged 3 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Children's Fractures Interest Group, Denmark · Not applicable, Interventional, and Treatment
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.
This clinical study will examine the treatment of displaced forearm fractures in children. Forearm fractures are very common in childhood. Most can be treated with a cast alone, but some fractures are too unstable or too badly displaced and need an operation to hold the bones in the correct position while they heal. In this study, we compare two types of intramedullary nails, which are thin rods placed inside the bone during surgery to stabilize the fracture. One type is made of titanium, which is the current standard treatment. The other type is bioabsorbable, which means it gradually dissolves in the body over time.
The main reason for studying the bioabsorbable nail is that it may allow children to avoid a second planned operation. In Denmark, titanium nails are usually removed in a later procedure, often 6 to 12 months after the first surgery. Even though that removal operation is generally safe, it still means another hospital visit, another anesthetic, another recovery period, and additional stress for the child and family. A dissolving nail could reduce this burden. However, because bioabsorbable nails are more flexible than titanium nails, there is a concern that the bone may heal a little more slowly.
The study will include children aged 3 to 13 years who have a displaced fracture in the shaft of one or both forearm bones and who need surgical treatment. Children who take part will be randomly assigned to one of two treatment groups. One group will receive a bioabsorbable nail and a cast for 4 weeks. The other group will receive a titanium nail and a cast for 2 weeks. The allocation is random so the two groups can be compared fairly. Families, the clinicians doing follow-up assessments, and the people evaluating the X-rays will, as far as possible, not know which type of nail the child received.
The main outcome in the study is how long it takes for the fracture to heal on X-ray. The study will also compare the two groups with respect to complications, pain, arm function, return to normal activities, and the child's and family's experience during recovery. The children will attend planned follow-up visits with clinical examinations and X-rays over time so the researchers can assess healing and safety in a standardized way.
Hypothesis:
The study hypothesis is that children treated with bioabsorbable intramedullary nails will have a healing time on X-ray that is not unacceptably longer than children treated with titanium nails. In other words, the researchers expect the bioabsorbable nail to provide nearly the same healing result as the titanium nail, while offering the important advantage that many children may avoid a second operation to remove the implant.
62 studies on the registry are indexed under Radius Fractures; 6 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 48 interventional studies indexed under Radius Fractures.
Browse Radius Fractures studies →Children's Fractures Interest Group, Denmark is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Intraoperative exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children in this arm receive surgical fixation with a bioabsorbable intramedullary nail, followed by above-elbow cast immobilization for 4 weeks.
Device: Bioabsorbable intramedullary nail
Children in this arm receive surgical fixation with a titanium elastic intramedullary nail, followed by above-elbow cast immobilization for 2 weeks.
Device: Titanium elastic 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.
Also known as: Activa IM-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.
Also known as: Titanium Elastic Nail System, TEN
Time to fracture healing (weeks)
Time in weeks from surgery/randomization (Day 0) to the first postoperative radiographic assessment meeting the predefined healing threshold, assessed using the modified Radiographic Union Score (mRUS). Healing is defined as mRUS ≥11, with bridging callus present in at least 3 of 4 cortices and no cortex scored 1; for both-bone fractures, both bones must meet this threshold at the same assessment.
Time frame: 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.
Range of motion
Active motion of the elbow, forearm, and wrist measured in degrees with a goniometer.
Time frame: From surgery/randomization (Day 0) to scheduled follow-up assessments at 2, 4, 6, and 12 weeks, and at 6 months, 1 year, and 2 years; if healing is delayed, also at 8 and 10 weeks.
Plan to share: No — De-identified individual participant data collected during this study will not be made publicly available. Due to the small sample size, single-center design, and pediatric population, there is a relevant risk of participant re-identification even after de-identification. Aggregate study results will be reported in publications and presentations.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Children's Fractures Interest Group, Denmark