Pediatric Overriding Distal Metaphyseal Radius FracturesNCT04323410
Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures
A study testing Cast immobilization and Percutaneus pinning in people with Pediatric Overriding Distal Metaphyseal Radius Fractures, run by Töölö Hospital at 1 site in Finland.
Trial summary
This is a randomized controlled trial comparing casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in under eleven years old children. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Pediatric Overriding Distal Metaphyseal Radius Fractures
- What is being tested?
- Cast immobilization and Percutaneus pinning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 29 Jun 2020to 31 Mar 2027
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with open epiphysis with closed overriding metaphyseal distal radial fracture with or without an associated fracture of the ulna
- Normal communication development (languages Finnish, Swedish, English)
Who cannot join
- Bilateral forearm injuries
- Gustillo-Anderson grade II or III open fracture
- Galeazzi fracture-dislocation
- Polytrauma
- Neurovascular injury of the ipsilateral upper extremity
- History of a displaced forearm fracture
- Underlying disease affecting fracture healing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
New Children's Hospital
Helsinki
Topi Laaksonen, MD, +358 50 427 1654, topi.laaksonen@hus.fi
About this study
Official title: Casting in Finger-trap Traction Without Reduction Versus Closed Reduction and Percutaneous Pin Fixation of Dorsally Displaced, Overriding Distal Metaphyseal Radius Fractures in Under Eleven Years Old Children
This is a randomized controlled trial comparing casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in under eleven years old children.
Read the detailed description
Overriding pediatric distal radius fractures have been managed with anatomical reduction performed under anesthesia with or without percutaneous pinning. This research protocol was developed due to good results reported on leaving the fractures in an overriding position.
In this randomized controlled trial, we will compare objective outcomes between casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in children.
Inclusion criteria are patients younger than 11 years old (Tanner 0) with completely overriding distal radius fractures. At the emergency department patients are randomized into two groups: finger trap traction and cast immobilization (experimental group) and anatomic reduction and percutaneous pin fixation (control group).
The current controversy is whether cast immobilization alone is an adequate stabilization or whether percutaneous pin fixation is more appropriate for displaced, complete, distal forearm (overriding) metaphyseal fractures. The objectives of this trial are to compare the outcomes between conservative treatment with finger trap method for completely displaced distal radius fractures and surgical treatment with percutaneous pinning. Our null hypothesis is that there are no radiological or clinically relevant differences in outcome measures between the two treatment groups. We consider non-inferiority proven if there is no clinically significant difference at 6 months between the two treatments groups in the primary outcome: ratio (%) of forearm rotation and wrist extension-flexion range of motion (ROM) compared to the non-affected side at 6 months (non-inferiority margin 10%).
- Being tested
- Cast immobilization, Percutaneus pinning
- Keywords
- bayonet fracture, paediatric fracture, distal forearm fracture, overriding fracture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast immobilizationProcedure or surgery
Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.
Percutaneus pinningProcedure or surgery
Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.
| Study group | Role | What they receive |
|---|---|---|
| Cast immobilization | Experimental | In the casting group, padded synthetic dorsal above elbow and volar below elbow splints are applied in ED without local or general anesthesia. Dorsal displacement and shortening of the radius are not corrected, but the forearm is attempted to be manipulated straight during application of the splints. The casted forearm is then supported by a collar and cuff sling. Splints are removed in an outpatient clinic at 4 weeks.
Cast immobilization is discontinued after 4 weeks and when the fracture site is nontender. If palpated tenderness is still present, the patient is given a dorsal forearm splint which can be removed (maximum of 2 weeks usage). Receives: Procedure: Cast immobilization |
| Percutaneus pinning | Active comparator | In the surgery group, a padded dorsal above elbow splint is applied in ED. Reduction and percutaneous pinning are performed under anesthesia in operating room by an experienced attending pediatric orthopedic surgeon within 7 days from the injury. Pin fixation is performed with two 1.6 mm pins. Padded dorsal above elbow and volar below elbow splints are applied. Splints and pins are removed at the outpatient clinic at 4 weeks after surgery. Receives: Procedure: Percutaneus pinning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist ROM
The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
Measured: 6 months
Forearm ROM
The ratio (injured side/non-injured side) in the total active forearm rotation.
Measured: 6 months
Secondary outcomes (8)
Patient-reported pain
Pain at rest and in activities is assessed on PedsQL questionnaire. Range 0 to 100 mm, 0 best.
Measured: 1 and 4 weeks, 3 and 6 months, 1 year
Patient-reported outcome (PROM)
Quick-DASH, range 0 to 100, 0 best
Measured: 4 weeks, 3 and 6 months, 1 year
Radiographic outcomes
Sagittal and coronal plain radiographs
Measured: 1 and 4 weeks, 3 and 6 months, 1 year
Grip strength
Objective grip strength measurement using dynamometer
Measured: 3 and 6 months, 1 year
Forearms length
Length of forearms and hands
Measured: 3 and 6 months, 1 year
Wrist ROM
The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
Measured: 3 months, 1 year
Forearm ROM
The ratio (injured side/non-injured side) in the total active forearm rotation.
Measured: 3 months, 1 year
Overall satisfaction
The patient's parent(s) or guardian(s) are queried about their satisfaction with the treatment. The satisfaction of the function of the fractured upper extremity and its effect on the patient's daily living and satisfaction to the cosmetic outcome are recorded on a 5-step Likert scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start29 Jun 2020
- Primary completion15 Sep 2025
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Overriding Distal Metaphyseal Radius FracturesStudies 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
- Non-inferiority randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Töölö Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Topi Laaksonen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323410
- Sponsor's protocol ID
- PediatricOverridingFractures
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2020
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laaksonen T, Stenroos A, Puhakka J, Kosola J, Kautiainen H, Ramo L, Nietosvaara Y. Casting in finger trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, over-riding distal metaphyseal radius fractures in children under 11 years old: a study protocol of a randomised controlled trial. BMJ Open. 2021 May 26;11(5):e045689. doi: 10.1136/bmjopen-2020-045689.
PubMed 34039573
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Casting in Finger-trap Traction Without Reduction Versus Closed Reduction and Percutaneous Pin Fixation of Dorsally Displaced, Overriding Distal Metaphyseal Radius Fractures in Under Eleven Years Old Children
- ClinicalTrials.gov ID
- NCT04323410
- Acronym / sponsor ID
- PediatricOverridingFractures
- Keywords
- bayonet fracture, paediatric fracture, distal forearm fracture, overriding fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Töölö HospitalUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Mar 2020 (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 is a randomized controlled trial comparing casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in under eleven years old children.
Detailed description
Overriding pediatric distal radius fractures have been managed with anatomical reduction performed under anesthesia with or without percutaneous pinning. This research protocol was developed due to good results reported on leaving the fractures in an overriding position.
In this randomized controlled trial, we will compare objective outcomes between casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in children.
Inclusion criteria are patients younger than 11 years old (Tanner 0) with completely overriding distal radius fractures. At the emergency department patients are randomized into two groups: finger trap traction and cast immobilization (experimental group) and anatomic reduction and percutaneous pin fixation (control group).
The current controversy is whether cast immobilization alone is an adequate stabilization or whether percutaneous pin fixation is more appropriate for displaced, complete, distal forearm (overriding) metaphyseal fractures. The objectives of this trial are to compare the outcomes between conservative treatment with finger trap method for completely displaced distal radius fractures and surgical treatment with percutaneous pinning. Our null hypothesis is that there are no radiological or clinically relevant differences in outcome measures between the two treatment groups. We consider non-inferiority proven if there is no clinically significant difference at 6 months between the two treatments groups in the primary outcome: ratio (%) of forearm rotation and wrist extension-flexion range of motion (ROM) compared to the non-affected side at 6 months (non-inferiority margin 10%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Non-inferiority randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cast immobilization | Experimental | Procedure: Cast immobilizationIn the casting group, padded synthetic dorsal above elbow and volar below elbow splints are applied in ED without local or general anesthesia. Dorsal displacement and shortening of the radius are not corrected, but the forearm is attempted to be manipulated straight during application of the splints. The casted forearm is then supported by a collar and cuff sling. Splints are removed in an outpatient clinic at 4 weeks. Cast immobilization is discontinued after 4 weeks and when the fracture site is nontender. If palpated tenderness is still present, the patient is given a dorsal forearm splint which can be removed (maximum of 2 weeks usage). |
| Percutaneus pinning | Active comparator | Procedure: Percutaneus pinningIn the surgery group, a padded dorsal above elbow splint is applied in ED. Reduction and percutaneous pinning are performed under anesthesia in operating room by an experienced attending pediatric orthopedic surgeon within 7 days from the injury. Pin fixation is performed with two 1.6 mm pins. Padded dorsal above elbow and volar below elbow splints are applied. Splints and pins are removed at the outpatient clinic at 4 weeks after surgery. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child with open epiphysis with closed overriding metaphyseal distal radial fracture with or without an associated fracture of the ulna
- Normal communication development (languages Finnish, Swedish, English)
Key exclusion criteria (7 listed)
- Bilateral forearm injuries
- Gustillo-Anderson grade II or III open fracture
- Galeazzi fracture-dislocation
- Polytrauma
- Neurovascular injury of the ipsilateral upper extremity
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 |
|---|---|---|
| Cast immobilizationCast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction. | Procedure or surgery | Cast immobilization |
| Percutaneus pinningReduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires. | Procedure or surgery | Percutaneus pinning |
Primary outcome
Wrist ROM
Time frame: 6 months
The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
Forearm ROM
Time frame: 6 months
The ratio (injured side/non-injured side) in the total active forearm rotation.
8 secondary outcomes
Patient-reported pain
Time frame: 1 and 4 weeks, 3 and 6 months, 1 year
Patient-reported outcome (PROM)
Time frame: 4 weeks, 3 and 6 months, 1 year
Radiographic outcomes
Time frame: 1 and 4 weeks, 3 and 6 months, 1 year
Grip strength
Time frame: 3 and 6 months, 1 year
Forearms length
Time frame: 3 and 6 months, 1 year
Wrist ROM
Time frame: 3 months, 1 year
Forearm ROM
Time frame: 3 months, 1 year
Overall satisfaction
Time frame: 6 months
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 25 Mar 2026.
- Derived from this study: PubMed 34039573Laaksonen T, Stenroos A, Puhakka J, Kosola J, Kautiainen H, Ramo L, Nietosvaara Y. Casting in finger trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, over-riding distal metaphyseal radius fractures in children under 11 years old: a study protocol of a randomised controlled trial. BMJ Open. 2021 May 26;11(5):e045689. doi: 10.1136/bmjopen-2020-045689.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cast immobilization and Percutaneus pinning in people with Pediatric Overriding Distal Metaphyseal Radius Fractures, run by Töölö Hospital at 1 site in Finland.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Mar 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 Finland. 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?
Contact Topi Laaksonen, MD (+358 50 427 1654, topi.laaksonen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist ROM (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04323410, which also lists 1 linked publication.
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 25 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.