Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: 7-12 Year Old; Both Bone Forearm Fracture; AO Classification 22D/2.1-5.2

Treatments: Procedure: Flexible intramedullary nail (FIN); Procedure: Reduction auder general anesthesia and long arm cast

Study type: Interventional

Funder types: Other

Identifiers

NCT04664517

78/1801/2020

Details and patient eligibility

About

The forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilization. Diaphyseal fractures in children have poor remodeling capacity, and malunion can thus cause permanent cosmetic and functional disability. Internal fixation especially with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared to closed reduction and cast immobilization.

Full description

This is a multicenter, randomized superiority trial comparing closed reduction and cast immobilization to flexible intramedullary nails in 7-12 year old children with > 10° of angulation and/or > 10mm of shortening in displaced both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2). A total of 78 patients with minimum 2 years of expected growth left are randomized in 1:1 ratio to either treatment group. The study has a parallel non-randomized patient preference arm. Both treatments are performed under general anesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilized in a collar and cuff sling for 4 weeks. Data is collected at baseline and at each follow-up until 1 year.

Primary outcome is 1) PROMIS Pediatric Item Bank v2.0 - Upper Extremity and 2) forearm pronation-supination range of motion at one-year follow-up. Secondary outcomes are Quick DASH, Pediatric pain questionnaire, Cosmetic VAS, wrist range of motion as well as any complications (malunion, delayed union, non-union or deep wound infection, peripheral nerve injury, need for re-intervention during 1-year follow-up) and costs of treatment.

The investigators hypothesize that flexible intramedullary nailing results in a superior outcome.

Enrollment: 90 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 7 to12 year old children
• Open distal radial physis
• Both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2)
• More than 10 degrees of angulation
• with or without less than 10mm of shortening

Exclusion criteria

• Patients with bilateral fractures
• Gustilo-Anderson grade I-III open fracture
• Neurovascular deficit
• Compartment syndrome
• Pathologic fracture
• Patient not able to give a written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 4 patient groups

FIN (Flexible intramedullary nail)

Active Comparator group

Description:

Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs.

Treatment:

Procedure: Flexible intramedullary nail (FIN)

Long arm cast

Active Comparator group

Description:

Fractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks.

Treatment:

Procedure: Reduction auder general anesthesia and long arm cast

Patient Choice FIN

Other group

Description:

Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs.

Treatment:

Procedure: Flexible intramedullary nail (FIN)

Patient Choice cast

Other group

Description:

Fractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks.

Treatment:

Procedure: Reduction auder general anesthesia and long arm cast