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Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

Forearm Fracture Clinical Trial

Official title:
Elastic Stable Intramedullary Nailing of Forearm Shaft Fractures by Titanium Compared With Biodegradable Nails: Results of a Prospective Randomized Trial in Children With at Least Two Years of Follow-up

Clinical Trial Summary

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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03474900
Study type Interventional
Source Oulu University Hospital
Contact
Status Completed
Phase N/A
Start date February 20, 2011
Completion date December 31, 2018
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