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Bioresorbable Intramedullary Nailing of Forearm Fractures

NCT04846543 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-04-15

No results posted yet for this study

Summary

The Activa IM-Nail™ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. The post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of Activa IM-Nail™.

Conditions

  • Forearm Fracture

Interventions

OTHER

MRI Scan

MRI scan

Sponsors & Collaborators

  • Bioretec Ltd.

    collaborator INDUSTRY

  • Thomas Klestil

    lead OTHER

Principal Investigators

  • Christoph Roeder, MD · Landesklinikum Baden/Moedling

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-09-30
Completion
2024-09-30

Countries

  • Austria
  • Denmark
  • France
  • Germany
  • Hungary
  • Portugal
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04846543 on ClinicalTrials.gov