Clinical trial NCT04941612: Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures
Official title: Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures: a Cohort Study of 30 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture Fixation, Intramedullary
Forearm Fracture
Fracture Healing
Child, Only
Implant Complication
Lead sponsor: Children's Fractures Interest Group, Denmark
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort study
Primary purpose: TREATMENT

Brief summary: Background

Pediatric diaphyseal forearm fractures are common and one of the most frequent reasons for orthopedic care. Fractures in need of surgery are often treated with metal Elastic Stable Intramedullary Nails (ESIN). Nail removal after 6-12 months is generally advocated. Surgical hardware removal has few complications; however, it is a substantial burden on the child, the family and healthcare economy. Bioabsorbable Intramedullary Nails (BIN) have been developed for the same indications as metal ESIN. The use of bioabsorbable implants would deem hardware removal unnecessary and relieve the child of further surgery and reduce healthcare costs.

Methods

The investigators aim to recruit all children in the catchment area of Herlev and Gentofte University Hospital (Copenhagen, Denmark) with acute unstable diaphyseal forearm fractures. Participants will be operated with BIN and followed consecutively for 2 years with interim analysis of data after 6 months. The investigators will report radiological healing using the Radiographic Union Score (RUS) 3 months after surgery together with any adverse events during follow-up.

Discussion

This study will provide important preliminary data and asses the feasibility of using the bioabsorbable Activa IM-Nail™ in pediatric diaphyseal forearm fractures. This study is a pilot study for initiating an RCT comparing BIN to metal ESIN hypothesizing that BIN is not an inferior treatment.


Eligibility criteria: Inclusion Criteria:

* Acute traumatic diaphyseal forearm fracture of the radius, ulna or both
* Fractures need to be complete (not unicortical or green stick)
* Displaced more than 50% of bone width or angulated more than 10° in any plane or irreducible or unstable after reduction

Exclusion Criteria:

We exclude patients

* with fractures that are well managed conservatively (undisplaced or minimally displaced)
* with previous ipsilateral forearm fracture
* with fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal)
* with fractures with ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants)
* unable to participate in follow-up
* with existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease)
* in whom internal fixation is otherwise contraindicated (e.g. active or potential infection)

Primary outcomes:
measure: Radiographic Union Score (RUS)
timeFrame: 3 months
Secondary outcomes:
measure: Faces Pain Scale - Revised (FPS-R)
timeFrame: 3 months
measure: Bilateral elbow and forearm range of motion
timeFrame: 3 months
measure: Visual Analogue Scale (VAS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte University Hospital
state: Capital Region
Study officials:
name: Morten J Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: