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Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

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ClinicalTrials.gov Identifier: NCT03474900
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : March 26, 2019
Sponsor:
Collaborators:
Oulu University Hospital
Bioretec Ltd.
Information provided by (Responsible Party):
Jaakko Sinikumpu, Oulu University Hospital

Study Description
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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).


Condition or disease Intervention/treatment Phase
Forearm Fracture Device: PLGA implant, Bioretec ltd. Finland Device: Titanium elastic stable nail Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients were randomised to 2 groups, titanium nailing or biodegradable nailing.
Masking: None (Open Label)
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.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 20, 2011
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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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 Name: 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 Name: elastic stable intramedullary nail


Outcome Measures
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Primary Outcome Measures :
  1. The range of motion (ROM) of forearm measured by goniometer [ Time Frame: 2 years ]
    The ROMs of forearm


Secondary Outcome Measures :
  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 Outcome Measures:
  1. adverse events [ Time Frame: 2 years ]
    all implant or treatment related adverse events like tissue reactions or re-factures


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474900


Locations
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Finland
Oulu University Hospital
Oulu, Finland
Sponsors and Collaborators
Jaakko Sinikumpu
Oulu University Hospital
Bioretec Ltd.
Investigators
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Principal Investigator: Juhani Merikanto, Ph.D. associate professor Central Finland, Central Hospital, Tampere, Finland
  Study Documents (Full-Text)

Documents provided by Jaakko Sinikumpu, Oulu University Hospital:
Study Protocol and Informed Consent Form  [PDF] February 5, 2018

More Information
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Publications of Results:

Other Publications:

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Responsible Party: Jaakko Sinikumpu, Head of childhood fracture and sport injury study, M.D., Ph.D., Oulu University Hospital
ClinicalTrials.gov Identifier: NCT03474900    
Other Study ID Numbers: Oulu University Hospital
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaakko Sinikumpu, Oulu University Hospital:
intramedullary nailing
randomised controlled trial
biodegradable
children
forearm shaft fractures
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries