Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

Forearm Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474900
• Other study ID #: Oulu University Hospital
• Status: Completed
• Phase: N/A
• Start date: February 20, 2011
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Oulu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Forearm Fracture
• Fractures, Bone

Intervention

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 (ß-TCP) which was manufactured by Bioretec Ltd. (Hartmaninkatu 2, Tampere, Finland)
• Titanium elastic stable nail
Elastic stable intramedullary nail to stabilize unstable forearm shaft fractures in children

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (3)

Lead Sponsor	Collaborator
Jaakko Sinikumpu	Bioretec Ltd., Oulu University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (33)

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 — View Citation

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Sinikumpu JJ, Keränen 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):25 — View Citation

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 Se — View Citation

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. — View Citation

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events	all implant or treatment related adverse events like tissue reactions or re-factures	2 years
Primary	The range of motion (ROM) of forearm measured by goniometer	The ROMs of forearm	2 years
Secondary	The range of motion (ROM) of elbow and wrist measured by goniometer	The ROMs of elbow and wrist	2 years
Secondary	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"	2 years
Secondary	Radiographic bone union	plain radiographs in anterior posterior (AP) and lateral projections	2 years
Secondary	Radiographic bone deformity	plain radiographs in anterior posterior and lateral projections	2 years
Secondary	Magnetic resonance imagining, bone healing	MRIs in intervention group	2 years
Secondary	Implant degeneration in Magnetic resonance imagining	degrading of the implant	2 years
Secondary	Magnetic resonance imagining, soft tissue reaction	soft tissue reaction	2 years