Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

NCT ID: NCT04323410

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2025-12-31

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.

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%).

Conditions

Pediatric Overriding Distal Metaphyseal Radius Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cast immobilization

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).

Group Type: EXPERIMENTAL

Cast immobilization

Intervention Type: PROCEDURE

Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.

Percutaneus pinning

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.

Group Type: ACTIVE_COMPARATOR

Percutaneus pinning

Intervention Type: PROCEDURE

Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.

Interventions

Cast immobilization

Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.

Intervention Type: PROCEDURE

Percutaneus pinning

Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Töölö Hospital

OTHER

Sponsor Role: lead

Responsible Party

Topi Laaksonen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

New Children's Hospital

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Topi Laaksonen, MD

Role: CONTACT

topi.laaksonen@hus.fi

+358 50 427 1654

Facility Contacts

Topi Laaksonen, MD

Role: primary

topi.laaksonen@hus.fi

+358 50 427 1654

References

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.

Reference Type: DERIVED

PMID: 34039573 (View on PubMed)

Other Identifiers

PediatricOverridingFractures

Identifier Type: -

Identifier Source: org_study_id