Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

March 24, 2019 updated by: Jaakko Sinikumpu

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaakko Sinikumpu

Collaborators

Oulu University Hospital
Bioretec Ltd.

Investigators

  • Principal Investigator: Juhani Merikanto, Ph.D. associate professor, Central Finland, Central Hospital, Tampere, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2011

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 24, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oulu University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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