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

Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures: a Cohort Study of 30 Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Child, Only; Implant Complication; Forearm Fracture; Fracture Healing; Fracture Fixation, Intramedullary
• Intervention / Treatment: Device: Activa IM-Nail

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Herlev, Capital Region, Denmark, 2730
      • Recruiting
      • Herlev and Gentofte University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Activa IM-Nail	Device: Activa IM-Nail; PLGA bioabsorbable intramedullary nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Union Score (RUS)	RUS is a score derived from assessing AP and lateral radiographs. Each bone cortex (anterior, posterior, medial and lateral) is assigned a score of 1 to 3. A cortex with a visible fracture line and no callus is given a score of 1, a cortex with callus but a visible fracture line is scored as 2 and a cortex with bridging callus and no visible fracture line is scored as 3. Scores are added to give a minimum score of 4 (definitely not healed) and a maximum of 12 (definitely healed). 12 is best.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faces Pain Scale - Revised (FPS-R)	To measure the outcome of pain in children below 8 years of age. Pain evaluated by the child selecting 1 of 6 faces that represents their feeling of pain. Faces are scored 0, 2, 4, 6, 8 or 10. Scale 0-10 with 2 point increments. 0 = no pain, 10= very much pain. 0 is best.	3 months
Bilateral elbow and forearm range of motion	Measured in degrees by goniometer	3 months
Visual Analogue Scale (VAS)	Pain evaluated by the child putting a mark on a 10 cm long line. Most left=no pain, most right=worst possible pain. Distance from most left to the child's mark is measured with a ruler. 1 mm = 1 point. Value is given with 1 decimal, e.g. 64 mm = 6,4 points. Scale 0.0-10.0. With 0 = no pain, 10= worst possible pain. 0 is best.	3 months

Collaborators and Investigators

• Sponsor: Children's Fractures Interest Group, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): May 25, 2025

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: H-21004012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No