NCT03474900

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Jaakko Sinikumpu · Academic / Other
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Accepted

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).

Conditions

• Forearm Fracture

Interventions

Type	Name	Description
DEVICE	PLGA implant, Bioretec ltd. Finland	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)
DEVICE	Titanium elastic stable nail	Elastic stable intramedullary nail to stabilize unstable forearm shaft fractures in children

Timeline

• Start date: 2011-02-20
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-03-23
• Last updated: 2019-03-26

Locations

1 site across 1 country: Finland