Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures

Children's Fractures Interest Group, Denmark

Status

Enrolling

Conditions

Forearm Fracture

Fracture Healing

Child, Only

Fracture Fixation, Intramedullary

Implant Complication

Treatments

Device: Activa IM-Nail

Study type

Interventional

Funder types

Other

Identifiers

NCT04941612

H-21004012

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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)