Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

Jaakko Sinikumpu

Status: Completed

Conditions: Forearm Fracture

Treatments: Device: Titanium elastic stable nail; Device: PLGA implant, Bioretec ltd. Finland

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03474900

Oulu University Hospital

Details and patient eligibility

About

There are disadvantages in Elastic Stable Intramedullary Nailing (ESIN) of forearm shaft fractures, such as soft tissue irritation and the need of implant removal. A new mini-invasive technique of intramedullary nailing with biodegradable material (BESIN) has been developed. The nails are tapped into the medullary cavity and left in place. The aim of this study was to compare BESIN technique with ESIN.

This is a prospective, randomized, controlled clinical trial including the patients (aged 5-15 years) who required operative treatment for forearm shaft fractures in two pediatric trauma centers, in Finland. The patients were randomized to be treated by BESIN or ESIN. Thirteen patients were required for each group, according to power analysis but altogether 35 were enrolled for potential drop-outs. Biodegradable polylactide-co-glycolide (PLGA) nails (ActivaNail ®, Bioretec ltd, Finland) were used in 19 and titanium nails (TEN ®, Synthes ltd, USA) in 16 patients. Pain and the range of motion (ROM) of forearm, elbow and wrist were primary outcomes. Radiographs and potential complications were analyzed of all and magnetic resonance imagines (MRI) of a randomly selected subgroup in BESIN group (N=13).

Enrollment: 35 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• suffering from single- or both-bone forearm shaft fracture
• child patient , age from 5 to 15 years
• surgical fixation needed, fracture is unstable
• cast immobilization is not rigid enough for the fracture treatment

Exclusion criteria

• open fractures with significant soft-tissue injury
• pathological fractures
• if patient has a previous fracture or infection in the same forearm
• patients with metabolic bone diseases, systematic disease
• patient uses the medication affecting bone quality
• resistance to infection
• fractures older than 7 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

PLGA implant, Bioretec ltd. Finland

Experimental group

Description:

Treatment with biodegradable elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population

Treatment:

Device: PLGA implant, Bioretec ltd. Finland

Titanium elastic stable nail

Active Comparator group

Description:

Treatment with titanium elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population

Treatment:

Device: Titanium elastic stable nail