Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

Not Applicable

Completed

• Conditions: Forearm Fracture

• Registration Number: NCT03474900
• Lead Sponsor: Jaakko Sinikumpu

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-20
• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-23
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-24
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The range of motion (ROM) of forearm measured by goniometer	2 years	The ROMs of forearm

Secondary Outcome Measures

Name	Time	Method
The range of motion (ROM) of elbow and wrist measured by goniometer	2 years	The ROMs of elbow and wrist
Magnetic resonance imagining, soft tissue reaction	2 years	soft tissue reaction
Implant degeneration in Magnetic resonance imagining	2 years	degrading of the implant
Pain measured with visual analogue scale	2 years	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"
Radiographic bone union	2 years	plain radiographs in anterior posterior (AP) and lateral projections
Radiographic bone deformity	2 years	plain radiographs in anterior posterior and lateral projections
Magnetic resonance imagining, bone healing	2 years	MRIs in intervention group

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland