Clinical trial NCT03474900: Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forearm Fracture
Keywords: intramedullary nailing
randomised controlled trial
biodegradable
children
forearm shaft fractures
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: Bioretec Ltd.
First posted: 2018-03-23
Enrollment: 35
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomised to 2 groups, titanium nailing or biodegradable nailing.
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: The range of motion (ROM) of forearm measured by goniometer
timeFrame: 2 years
Secondary outcomes:
measure: The range of motion (ROM) of elbow and wrist measured by goniometer
timeFrame: 2 years
measure: Pain measured with visual analogue scale
timeFrame: 2 years
measure: Radiographic bone union
timeFrame: 2 years
measure: Radiographic bone deformity
timeFrame: 2 years
measure: Magnetic resonance imagining, bone healing
timeFrame: 2 years
measure: Implant degeneration in Magnetic resonance imagining
timeFrame: 2 years
measure: Magnetic resonance imagining, soft tissue reaction
timeFrame: 2 years
Other outcomes:
measure: adverse events
timeFrame: 2 years
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Central Finland, Central Hospital, Tampere, Finland
name: Juhani Merikanto, Ph.D. associate professor
role: PRINCIPAL_INVESTIGATOR
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