Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures
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
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedStudy Start
First participant enrolled
June 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedMarch 25, 2026
March 1, 2026
5.2 years
March 24, 2020
March 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Wrist ROM
The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
6 months
Forearm ROM
The ratio (injured side/non-injured side) in the total active forearm rotation.
6 months
Secondary Outcomes (8)
Patient-reported pain
1 and 4 weeks, 3 and 6 months, 1 year
Patient-reported outcome (PROM)
4 weeks, 3 and 6 months, 1 year
Radiographic outcomes
1 and 4 weeks, 3 and 6 months, 1 year
Grip strength
3 and 6 months, 1 year
Forearms length
3 and 6 months, 1 year
- +3 more secondary outcomes
Study Arms (2)
Cast immobilization
EXPERIMENTALIn 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 COMPARATORIn 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.
Interventions
Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.
Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Töölö Hospitallead
Study Sites (1)
New Children's Hospital
Helsinki, Finland
Related Publications (1)
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.
PMID: 34039573DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 24, 2020
First Posted
March 26, 2020
Study Start
June 29, 2020
Primary Completion
September 15, 2025
Study Completion (Estimated)
March 31, 2027
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share