Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

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

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).

intramedullary nailing, randomised controlled trial, biodegradable, children, forearm shaft fractures

The patient was informed about the treatment method that he or she was randomised. The operating surgeon knew the group and treatment that the patient belonged to.

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

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

The investigational implant is an ultra-high-strength biodegradable intramedullary (IM) nail of poly(lactide-co-glycolide) (PLGA)/tricalcium-phosphate (β-TCP) which was manufactured by Bioretec Ltd. (Hartmaninkatu 2, Tampere, Finland)

general pain or pain at the fracture site in mm +/- SD , scale is from 0-100mm in visual scale where child can point the proper level of pain. 0 equals "no pain", 100 equals "the highest imaginable pain"

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

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