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

NCT07536581 | Not Yet Recruiting DMC

• 1 other identifier: 16-0302-99
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Randomized Controlled Trial (RCT); pediatric forearm fracture; forearm shaft fracture in children; elastic stable intramedullary nailingelastic stable intramedullary nailing; ESIN; titanium elastic nail; bioabsorbable intramedullary nail; TEN; BIN; radiographic healing; radiographic union; modified Radiographic Union Score; mRUS; non-inferiority trial; randomized trial

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

• Range of motion

  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.

Study Arms (2)

Bioabsorbable intramedullary nail (BIN)

EXPERIMENTAL

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

Titanium elastic nail (TEN)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Activa IM-Nail™

Bioabsorbable intramedullary nail (BIN)

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.

Also known as: Titanium Elastic Nail System, TEN

Titanium elastic nail (TEN)

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Children's Fractures Interest Group, Denmark: lead

Study Sites (1)

Copenhagen University Hospital - Herlev

København NV, 2400, Denmark

Location

Related Publications (3)

• Korhonen L, Perhomaa M, Kyro A, Pokka T, Serlo W, Merikanto J, Sinikumpu JJ. Intramedullary nailing of forearm shaft fractures by biodegradable compared with titanium nails: Results of a prospective randomized trial in children with at least two years of follow-up. Biomaterials. 2018 Dec;185:383-392. doi: 10.1016/j.biomaterials.2018.09.011. Epub 2018 Sep 11.

  PMID: 30292588 BACKGROUND

• Simanovsky N, Tair MA, Simanovsky N, Porat S. Removal of flexible titanium nails in children. J Pediatr Orthop. 2006 Mar-Apr;26(2):188-92. doi: 10.1097/01.bpo.0000218534.51609.aa.

  PMID: 16557132 BACKGROUND

• Lascombes P, Haumont T, Journeau P. Use and abuse of flexible intramedullary nailing in children and adolescents. J Pediatr Orthop. 2006 Nov-Dec;26(6):827-34. doi: 10.1097/01.bpo.0000235397.64783.d6.

  PMID: 17065959 BACKGROUND

MeSH Terms

Conditions

Forearm Injuries; Radius Fractures; Ulna Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Study Officials

• Morten J Andersen, MD

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The following parties will be masked to treatment allocation: the participants, the parents, postoperative ward and outpatient clinic caregivers involved in routine care, clinicians performing follow-up assessments, radiograph reviewers, occupational/hand therapists performing functional assessments, and the statistician/data analyst. Participants and parents will remain masked until completion of the 6-month follow-up visit, unless earlier unblinding is required for patient safety. The operating surgeon and operating room staff cannot be masked because they must know which implant is used during surgery. A limited number of designated study personnel will remain unblinded for device logistics and, when relevant, planning of elective titanium nail removal.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Trauma

Model Details: This is a single-center, randomized, parallel-group, blinded, non-inferiority interventional trial. Children aged 3-13 years with displaced diaphyseal forearm fractures requiring operative fixation are randomized 1:1 to one of two active surgical treatment arms: bioabsorbable intramedullary nails or titanium elastic nails. The trial compares these two standardized operative strategies to determine whether time to radiographic healing with bioabsorbable nails is non-inferior to titanium nails. The design includes age stratification and equal allocation between groups.

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)