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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03474900

Enrollment

Registered

2018-03-23

Start date

2011-02-20

Completion date

2018-12-31

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Forearm Fracture

Keywords

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

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).

Interventions

DEVICEPLGA 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)

DEVICETitanium elastic stable nail

Elastic stable intramedullary nail to stabilize unstable forearm shaft fractures in children

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

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.

Intervention model description

The patients were randomised to 2 groups, titanium nailing or biodegradable nailing.

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The range of motion (ROM) of forearm measured by goniometer	2 years	The ROMs of forearm

Secondary

Measure	Time frame	Description
The range of motion (ROM) of elbow and wrist measured by goniometer	2 years	The ROMs of elbow and wrist
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
Magnetic resonance imagining, bone healing	2 years	MRIs in intervention group
Implant degeneration in Magnetic resonance imagining	2 years	degrading of the implant
Magnetic resonance imagining, soft tissue reaction	2 years	soft tissue reaction
Radiographic bone deformity	2 years	plain radiographs in anterior posterior and lateral projections

Other

Measure	Time frame	Description
adverse events	2 years	all implant or treatment related adverse events like tissue reactions or re-factures

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026