NCT04941612

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

Status unknown NA Last updated 28 June 2021

What this trial tests

NA trial testing Activa IM-Nail in Fracture Fixation, Intramedullary in 30 participants. Status unknown.

Timeline

25 May 2021

Primary endpoint
31 August 2023

25 May 2025

Quick facts

Lead sponsor	Children's Fractures Interest Group, Denmark
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	25 May 2021
Primary completion	31 August 2023
Estimated completion	25 May 2025
Sites	1 location across Denmark

Drugs / interventions tested

• Activa IM-Nail

Conditions studied

• Fracture Fixation, Intramedullary — all drugs for Fracture Fixation, Intramedullary →
• Forearm Fracture — all drugs for Forearm Fracture →
• Fracture Healing — all drugs for Fracture Healing →
• Child, Only — all drugs for Child, Only →

Sponsor

Children's Fractures Interest Group, Denmark

Who can join

Adults 2 to 18, any sex, with Fracture Fixation, Intramedullary or Forearm Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. PLGA-Based Nanomedicine: History of Advancement and Development in Clinical Applications of Multiple Diseases.
   Alsaab HO, Alharbi FD, Alhibs AS, Alanazi NB, et al · · 2022 · cited 141× · PMID 36559223 · DOI 10.3390/pharmaceutics14122728