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Forearm FractureNCT03474900

Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

A study testing PLGA implant, Bioretec ltd. Finland and Titanium elastic stable nail in people with Forearm Fracture, run by Jaakko Sinikumpu at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Forearm Fracture
What is being tested?
PLGA implant, Bioretec ltd. Finland and Titanium elastic stable nail
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteFinland
Study dates
20 Feb 2011to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Oulu University Hospital

    Oulu

Other trials in Finland

About this study

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

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).

Being tested
PLGA implant, Bioretec ltd. Finland, Titanium elastic stable nail
Keywords
intramedullary nailing, randomised controlled trial, biodegradable, children, forearm shaft fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLGA implant, Bioretec ltd. FinlandDevice

    Also called Biodegradable elastic stable intramedullary nail

    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)

  • Titanium elastic stable nailDevice

    Also called elastic stable intramedullary nail

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

Study groups in NCT03474900
Study groupRoleWhat they receive
PLGA implant, Bioretec ltd. FinlandExperimentalTreatment with biodegradable elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population
Receives: Device: PLGA implant, Bioretec ltd. Finland
Titanium elastic stable nailActive comparatorTreatment with titanium elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population
Receives: Device: Titanium elastic stable nail

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The ROMs of forearm

    Measured: 2 years

Secondary outcomes (7)

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

    The ROMs of elbow and wrist

    Measured: 2 years

  2. 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"

    Measured: 2 years

  3. Radiographic bone union

    plain radiographs in anterior posterior (AP) and lateral projections

    Measured: 2 years

  4. Radiographic bone deformity

    plain radiographs in anterior posterior and lateral projections

    Measured: 2 years

  5. Magnetic resonance imagining, bone healing

    MRIs in intervention group

    Measured: 2 years

  6. Implant degeneration in Magnetic resonance imagining

    degrading of the implant

    Measured: 2 years

  7. Magnetic resonance imagining, soft tissue reaction

    soft tissue reaction

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2018
  2. Study start20 Feb 2011
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients were randomised to 2 groups, titanium nailing or biodegradable nailing.
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03474900
Sponsor's protocol ID
Oulu University Hospital
Status last verified
Mar 2019
First submitted
5 Jan 2018
Last updated
26 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baldwin K, Morrison MJ 3rd, Tomlinson LA, Ramirez R, Flynn JM. Both bone forearm fractures in children and adolescents, which fixation strategy is superior - plates or nails? A systematic review and meta-analysis of observational studies. J Orthop Trauma. 2014 Jan;28(1):e8-e14. doi: 10.1097/BOT.0b013e31829203ea.

    PubMed 23542745

  • Bostman O, Makela EA, Tormala P, Rokkanen P. Transphyseal fracture fixation using biodegradable pins. J Bone Joint Surg Br. 1989 Aug;71(4):706-7. doi: 10.1302/0301-620X.71B4.2549074. No abstract available.

    PubMed 2549074

  • Branch LG, Crantford C, Cunningham T, Bharti G, Thompson J, Couture D, David LR. Long-Term Outcomes of Pediatric Cranial Reconstruction Using Resorbable Plating Systems for the Treatment of Craniosynostosis. J Craniofac Surg. 2017 Jan;28(1):26-29. doi: 10.1097/SCS.0000000000003166.

    PubMed 27831975

  • Garg NK, Ballal MS, Malek IA, Webster RA, Bruce CE. Use of elastic stable intramedullary nailing for treating unstable forearm fractures in children. J Trauma. 2008 Jul;65(1):109-15. doi: 10.1097/TA.0b013e3181623309.

    PubMed 18580539

  • Gorter EA, Vos DI, Sier CF, Schipper IB. Implant removal associated complications in children with limb fractures due to trauma. Eur J Trauma Emerg Surg. 2011 Dec;37(6):623-7. doi: 10.1007/s00068-011-0087-4. Epub 2011 Mar 17.

    PubMed 22207879

  • Helenius I, Lamberg TS, Kaariainen S, Impinen A, Pakarinen MP. Operative treatment of fractures in children is increasing. A population-based study from Finland. J Bone Joint Surg Am. 2009 Nov;91(11):2612-6. doi: 10.2106/JBJS.H.01519.

    PubMed 19884435

  • Herman MJ, Marshall ST. Forearm fractures in children and adolescents: a practical approach. Hand Clin. 2006 Feb;22(1):55-67. doi: 10.1016/j.hcl.2005.10.003.

    PubMed 16504778

  • Hope PG, Williamson DM, Coates CJ, Cole WG. Biodegradable pin fixation of elbow fractures in children. A randomised trial. J Bone Joint Surg Br. 1991 Nov;73(6):965-8. doi: 10.1302/0301-620X.73B6.1659570.

    PubMed 1659570

  • Hughes TB. Bioabsorbable implants in the treatment of hand fractures: an update. Clin Orthop Relat Res. 2006 Apr;445:169-74. doi: 10.1097/01.blo.0000205884.81328.cc.

    PubMed 16505724

  • Korhonen J, Sinikumpu JJ, Harmainen S, Ryhanen J, Kallio P, Serlo W. [Removal of osteosynthesis material in children and young people]. Duodecim. 2014;130(7):689-95. Finnish.

    PubMed 24772785

  • Lascombes P, Nespola A, Poircuitte JM, Popkov D, de Gheldere A, Haumont T, Journeau P. Early complications with flexible intramedullary nailing in childhood fracture: 100 cases managed with precurved tip and shaft nails. Orthop Traumatol Surg Res. 2012 Jun;98(4):369-75. doi: 10.1016/j.otsr.2011.11.011. Epub 2012 May 14.

    PubMed 22583892

  • Lieber J, Schmittenbecher P. Developments in the treatment of pediatric long bone shaft fractures. Eur J Pediatr Surg. 2013 Dec;23(6):427-33. doi: 10.1055/s-0033-1360460. Epub 2013 Dec 10.

    PubMed 24327219

  • Makki D, Matar HE, Webb M, Wright DM, James LA, Ricketts DM. Elastic stable intramedullary nailing in paediatric forearm fractures: the rate of open reduction and complications. J Pediatr Orthop B. 2017 Sep;26(5):412-416. doi: 10.1097/BPB.0000000000000408.

    PubMed 27832017

  • Middleton JC, Tipton AJ. Synthetic biodegradable polymers as orthopedic devices. Biomaterials. 2000 Dec;21(23):2335-46. doi: 10.1016/s0142-9612(00)00101-0.

    PubMed 11055281

  • Prakasam M, Locs J, Salma-Ancane K, Loca D, Largeteau A, Berzina-Cimdina L. Biodegradable Materials and Metallic Implants-A Review. J Funct Biomater. 2017 Sep 26;8(4):44. doi: 10.3390/jfb8040044.

    PubMed 28954399

Questions about this trial

What is this clinical trial studying?

A study testing PLGA implant, Bioretec ltd. Finland and Titanium elastic stable nail in people with Forearm Fracture, run by Jaakko Sinikumpu at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The range of motion (ROM) of forearm measured by goniometer (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03474900, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.

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