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NCT Number: NCT03474900

Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

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).

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Key information

Conditions

Forearm Fracture

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PLGA implant, Bioretec ltd. Finland

Device

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)

Other names: Biodegradable elastic stable intramedullary nail

Titanium elastic stable nail

Device

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

Other names: elastic stable intramedullary nail

Primary outcomes

  1. The range of motion (ROM) of forearm measured by goniometer

    Time frame: 2 years

    The ROMs of forearm

Secondary outcomes

  1. The range of motion (ROM) of elbow and wrist measured by goniometer

    Time frame: 2 years

    The ROMs of elbow and wrist

  2. Pain measured with visual analogue scale

    Time frame: 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"

  3. Radiographic bone union

    Time frame: 2 years

    plain radiographs in anterior posterior (AP) and lateral projections

  4. Radiographic bone deformity

    Time frame: 2 years

    plain radiographs in anterior posterior and lateral projections

  5. Magnetic resonance imagining, bone healing

    Time frame: 2 years

    MRIs in intervention group

  6. Implant degeneration in Magnetic resonance imagining

    Time frame: 2 years

    degrading of the implant

  7. Magnetic resonance imagining, soft tissue reaction

    Time frame: 2 years

    soft tissue reaction

Other outcomes

  1. adverse events

    Time frame: 2 years

    all implant or treatment related adverse events like tissue reactions or re-factures

Sponsors and collaborators

Lead sponsor

Jaakko Sinikumpu

Other

Collaborators

  • Bioretec Ltd.
  • Oulu University Hospital

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2018
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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