Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

NCT03474900 | Completed

• 1 other identifier: Oulu University Hospital
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Forearm Fracture

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The range of motion (ROM) of forearm measured by goniometer

  The ROMs of forearm

  2 years

Secondary Outcomes (7)

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

  2 years

• Pain measured with visual analogue scale

  2 years

• Radiographic bone union

  2 years

• Radiographic bone deformity

  2 years

• Magnetic resonance imagining, bone healing

  2 years

Other Outcomes (1)

• adverse events

  2 years

Study Arms (2)

PLGA implant, Bioretec ltd. Finland

EXPERIMENTAL

Treatment with biodegradable elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population

Device: PLGA implant, Bioretec ltd. Finland

Titanium elastic stable nail

ACTIVE COMPARATOR

Treatment with titanium elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population

Device: Titanium elastic stable nail

Interventions

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)

Also known as: Biodegradable elastic stable intramedullary nail

PLGA implant, Bioretec ltd. Finland

Titanium elastic stable nail DEVICE

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

Also known as: elastic stable intramedullary nail

Titanium elastic stable nail

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaakko Sinikumpu: lead
• Oulu University Hospital: collaborator
• Bioretec Ltd.: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, Finland

Location

Related Publications (33)

• 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.

  PMID: 23542745 BACKGROUND

• 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.

  PMID: 2549074 BACKGROUND

• 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.

  PMID: 27831975 BACKGROUND

• 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.

  PMID: 18580539 BACKGROUND

• 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.

  PMID: 22207879 BACKGROUND

• 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.

  PMID: 19884435 BACKGROUND

• 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.

  PMID: 16504778 BACKGROUND

• 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.

  PMID: 1659570 BACKGROUND

• 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.

  PMID: 16505724 BACKGROUND

• 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.

  PMID: 24772785 BACKGROUND

• 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.

  PMID: 22583892 BACKGROUND

• 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.

  PMID: 24327219 BACKGROUND

• 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.

  PMID: 27832017 BACKGROUND

• 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.

  PMID: 11055281 BACKGROUND

• 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.

  PMID: 28954399 BACKGROUND

• Sinikumpu JJ, Lautamo A, Pokka T, Serlo W. The increasing incidence of paediatric diaphyseal both-bone forearm fractures and their internal fixation during the last decade. Injury. 2012 Mar;43(3):362-6. doi: 10.1016/j.injury.2011.11.006. Epub 2011 Dec 6.

  PMID: 22154046 BACKGROUND

• van der Eng DM, Schep NW, Schepers T. Bioabsorbable Versus Metallic Screw Fixation for Tibiofibular Syndesmotic Ruptures: A Meta-Analysis. J Foot Ankle Surg. 2015 Jul-Aug;54(4):657-62. doi: 10.1053/j.jfas.2015.03.014. Epub 2015 May 8.

  PMID: 25960058 BACKGROUND

• Wall L, O'Donnell JC, Schoenecker PL, Keeler KA, Dobbs MB, Luhmann SJ, Gordon JE. Titanium elastic nailing radius and ulna fractures in adolescents. J Pediatr Orthop B. 2012 Sep;21(5):482-8. doi: 10.1097/BPB.0b013e3283528db5.

  PMID: 22415404 BACKGROUND

• Waris E, Konttinen YT, Ashammakhi N, Suuronen R, Santavirta S. Bioabsorbable fixation devices in trauma and bone surgery: current clinical standing. Expert Rev Med Devices. 2004 Nov;1(2):229-40. doi: 10.1586/17434440.1.2.229.

  PMID: 16293043 BACKGROUND

• Barber FA, Spenciner DB, Bhattacharyya S, Miller LE. Biocomposite Implants Composed of Poly(Lactide-co-Glycolide)/beta-Tricalcium Phosphate: Systematic Review of Imaging, Complication, and Performance Outcomes. Arthroscopy. 2017 Mar;33(3):683-689. doi: 10.1016/j.arthro.2016.09.032. Epub 2016 Dec 18.

  PMID: 27998641 RESULT

• Andaloussi S, Amine Oukhouya M, Alaoui O, Atarraf K, Chater L, Afifi MA. [Elastic stable intramedullary nailing (ESIN) in the treatment of both-bone forearm fractures in the child: about 87 cases]. Pan Afr Med J. 2017 May 30;27:68. doi: 10.11604/pamj.2017.27.68.11058. eCollection 2017. French.

  PMID: 28819489 RESULT

• Cullen MC, Roy DR, Giza E, Crawford AH. Complications of intramedullary fixation of pediatric forearm fractures. J Pediatr Orthop. 1998 Jan-Feb;18(1):14-21.

  PMID: 9449095 RESULT

• Dave MB, Parmar KD, Sachde BA. The Radial Bow following Square Nailing in Radius and Ulna Shaft Fractures in Adults and its Relation to Disability and Function. Malays Orthop J. 2016 Jul;10(2):11-15. doi: 10.5704/MOJ.1607.003.

  PMID: 28435555 RESULT

• Fernandez FF, Langendorfer M, Wirth T, Eberhardt O. Failures and complications in intramedullary nailing of children's forearm fractures. J Child Orthop. 2010 Apr;4(2):159-67. doi: 10.1007/s11832-010-0245-y. Epub 2010 Feb 24.

  PMID: 21455473 RESULT

• Firl M, Wunsch L. Measurement of bowing of the radius. J Bone Joint Surg Br. 2004 Sep;86(7):1047-9. doi: 10.1302/0301-620x.86b7.14294.

  PMID: 15446536 RESULT

• Krucinska I, Zywicka B, Komisarczyk A, Szymonowicz M, Kowalska S, Zaczynska E, Struszczyk M, Czarny A, Jadczyk P, Uminska-Wasiluk B, Rybak Z, Kowalczuk M. Biological Properties of Low-Toxicity PLGA and PLGA/PHB Fibrous Nanocomposite Implants for Osseous Tissue Regeneration. Part I: Evaluation of Potential Biotoxicity. Molecules. 2017 Nov 29;22(12):2092. doi: 10.3390/molecules22122092.

  PMID: 29186078 RESULT

• Kruppa C, Bunge P, Schildhauer TA, Dudda M. Low complication rate of elastic stable intramedullary nailing (ESIN) of pediatric forearm fractures: A retrospective study of 202 cases. Medicine (Baltimore). 2017 Apr;96(16):e6669. doi: 10.1097/MD.0000000000006669.

  PMID: 28422876 RESULT

• Sarmiento A, Ebramzadeh E, Brys D, Tarr R. Angular deformities and forearm function. J Orthop Res. 1992 Jan;10(1):121-33. doi: 10.1002/jor.1100100115.

  PMID: 1727932 RESULT

• Sinikumpu JJ, Keranen J, Haltia AM, Serlo W, Merikanto J. A new mini-invasive technique in treating pediatric diaphyseal forearm fractures by bioabsorbable elastic stable intramedullary nailing: a preliminary technical report. Scand J Surg. 2013;102(4):258-64. doi: 10.1177/1457496913490459. Epub 2013 Sep 20.

  PMID: 24056134 RESULT

• Sinikumpu JJ, Lautamo A, Pokka T, Serlo W. Complications and radiographic outcome of children's both-bone diaphyseal forearm fractures after invasive and non-invasive treatment. Injury. 2013 Apr;44(4):431-6. doi: 10.1016/j.injury.2012.08.032. Epub 2012 Sep 15.

  PMID: 22986071 RESULT

• Tarr RR, Garfinkel AI, Sarmiento A. The effects of angular and rotational deformities of both bones of the forearm. An in vitro study. J Bone Joint Surg Am. 1984 Jan;66(1):65-70.

  PMID: 6690445 RESULT

• Wilkins KE. Principles of fracture remodeling in children. Injury. 2005 Feb;36 Suppl 1:A3-11. doi: 10.1016/j.injury.2004.12.007.

  PMID: 15652934 RESULT

• Xue AS, Koshy JC, Weathers WM, Wolfswinkel EM, Kaufman Y, Sharabi SE, Brown RH, Hicks MJ, Hollier LH Jr. Local foreign-body reaction to commercial biodegradable implants: an in vivo animal study. Craniomaxillofac Trauma Reconstr. 2014 Mar;7(1):27-34. doi: 10.1055/s-0033-1364199. Epub 2014 Jan 9.

  PMID: 24624254 RESULT

Study Officials

• Juhani Merikanto, Ph.D. associate professor

  Central Finland, Central Hospital, Tampere, Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of childhood fracture and sport injury study, M.D., Ph.D.

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

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: March 23, 2018
• Study Start: February 20, 2011
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)