Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Forearm Fracture

Intervention / Treatment
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* Device: PLGA implant, Bioretec ltd. Finland
* Device: Titanium elastic stable nail


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients were randomised to 2 groups, titanium nailing or biodegradable nailing.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLGA implant, Bioretec ltd. Finland<br>Treatment with biodegradable elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population | Device: PLGA implant, Bioretec ltd. Finland<br>* 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)<br>* Other names: Biodegradable elastic stable intramedullary nail;|
| Active Comparator: Titanium elastic stable nail<br>Treatment with titanium elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population | Device: Titanium elastic stable nail<br>* Elastic stable intramedullary nail to stabilize unstable forearm shaft fractures in children<br>* Other names: elastic stable intramedullary nail;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The range of motion (ROM) of forearm measured by goniometer | The ROMs of forearm | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intramedullary nailing, randomised controlled trial, biodegradable, children, forearm shaft fractures