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

April 17, 2026 updated by: Morten Jon Andersen, Children's Fractures Interest Group, Denmark

Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails: A Single-Center, Multi-Blinded, Randomized Parallel-Group, Non-Inferiority Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • København NV, Denmark, 2400
        • Copenhagen University Hospital - Herlev
        • Contact:
        • Principal Investigator:
          • Morten J Andersen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bioabsorbable intramedullary nail (BIN)
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
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.
Other Names:
  • Activa IM-Nail™
Active Comparator: Titanium elastic nail (TEN)
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
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.
Other Names:
  • TEN
  • Titanium Elastic Nail System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to fracture healing (weeks)
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
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.
Active motion of the elbow, forearm, and wrist measured in degrees with a goniometer.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Fractures Interest Group, Denmark

Investigators

  • Principal Investigator: Morten J Andersen, MD, Copenhagen University Hospital at Herlev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

April 11, 2026

First Submitted That Met QC Criteria

April 11, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0302-99

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adolescent

Clinical Trials on Bioabsorbable intramedullary nail

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe