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

NCT04941612 | Unknown

• 1 other identifier: H-21004012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture Fixation, Intramedullary; Forearm Fracture; Fracture Healing; Child, Only; Implant Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Faces Pain Scale - Revised (FPS-R)

  3 months

• Bilateral elbow and forearm range of motion

  3 months

• Visual Analogue Scale (VAS)

  3 months

Study Arms (1)

Activa IM-Nail

EXPERIMENTAL

Activa IM-Nail

Device: Activa IM-Nail

Interventions

Activa IM-Nail DEVICE

PLGA bioabsorbable intramedullary nail

Activa IM-Nail

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Fractures Interest Group, Denmark: lead

Study Sites (1)

Herlev and Gentofte University Hospital

Herlev, Capital Region, 2730, Denmark

RECRUITING

Study Officials

• Morten J Andersen, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten J Andersen, MD

CONTACT

004538681479; mortenjonandersen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Orthopedic Surgeon

Model Details: Cohort study

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 28, 2021
• Study Start: May 25, 2021
• Primary Completion: August 31, 2023
• Study Completion: May 25, 2025
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)