Forearm InjuriesFORESTNCT07536581
Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails
A study testing Bioabsorbable intramedullary nail and Titanium elastic intramedullary nail in people with Forearm Injuries and Radius Fractures, run by Children's Fractures Interest Group, Denmark at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Forearm Injuries, Radius Fractures, Ulna Fractures
- What is being tested?
- Bioabsorbable intramedullary nail and Titanium elastic intramedullary nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2026to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Copenhagen University Hospital - Herlev
København NV, 2400
Morten J Andersen, MD, 004526148624, mortenjonandersen@gmail.com
Morten J Andersen, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Forearm Injuries, Radius Fractures, Ulna Fractures, Fractures, Bone, Child, Adolescent
- Being tested
- Bioabsorbable intramedullary nail, Titanium elastic intramedullary nail
- 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
- Medical subject headings
- Forearm Injuries, Radius Fractures, Ulna Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioabsorbable intramedullary nailDevice
Also called Activa IM-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.
Titanium elastic intramedullary nailDevice
Also called Titanium Elastic Nail System, TEN
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Titanium elastic intramedullary nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Active motion of the elbow, forearm, and wrist measured in degrees with a goniometer.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMay 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Forearm InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Fractures Interest Group, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Jon Andersen, Copenhagen University Hospital at Herlev
- Investigators
- Morten J Andersen, MD, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536581
- Sponsor's protocol ID
- 16-0302-99
- Acronym
- FOREST
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 30292588Simanovsky 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.
PubMed 16557132Lascombes 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.
PubMed 17065959
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07536581
- Acronym / sponsor ID
- FOREST / 16-0302-99
- Conditions
- Forearm Injuries, Radius Fractures, Ulna Fractures, Fractures, Bone, Child, Adolescent
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Fractures Interest Group, DenmarkUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bioabsorbable intramedullary nail (BIN) | Experimental | Device: Bioabsorbable intramedullary nailChildren in this arm receive surgical fixation with a bioabsorbable intramedullary nail, followed by above-elbow cast immobilization for 4 weeks. |
| Titanium elastic nail (TEN) | Active comparator | Device: Titanium elastic intramedullary nailChildren in this arm receive surgical fixation with a titanium elastic intramedullary nail, followed by above-elbow cast immobilization for 2 weeks. |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioabsorbable intramedullary nailAlso: Activa IM-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. | Device | Bioabsorbable intramedullary nail (BIN) |
| Titanium elastic intramedullary nailAlso: Titanium Elastic Nail System, TENTitanium 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. | Device | Titanium elastic nail (TEN) |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 30292588Korhonen 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.
- Background: PubMed 16557132Simanovsky 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.
- Background: PubMed 17065959Lascombes 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Morten J Andersen, MD principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioabsorbable intramedullary nail and Titanium elastic intramedullary nail in people with Forearm Injuries and Radius Fractures, run by Children's Fractures Interest Group, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07536581, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.