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

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

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Bioabsorbable intramedullary nail
Device
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.
Titanium elastic intramedullary nail
Device
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Bioabsorbable intramedullary nail (BIN)Experimental treatment 1 intervention

Group B: Titanium elastic nail (TEN)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Fractures Interest Group, Denmark

Lead sponsor

Copenhagen University Hospital at Herlev

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: