NCT04846543

Brief 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™.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
7 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

April 13, 2021

Last Update Submit

April 13, 2021

Conditions

Forearm Fracture

Outcome Measures

Primary Outcomes (1)

  • Refracture rate

    Assessment of refracture rate

    First year after operation

Secondary Outcomes (4)

  • Absorption of implant

    One and two years after operation

  • Bony union

    One year after operation

  • Monteggia lesion and equivalent

    2 years after operation

  • Cost effectiveness

    1 year after operation

Study Arms (1)

MRI scan 1st and 2nd year

OTHER

Additionally to routinely follow up, there will be an MRI scan of enrolled patients after one and two years in some of the study sites

Other: MRI Scan

Interventions

MRI ScanOTHER

MRI scan

MRI scan 1st and 2nd year

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diaphyseal forearm fractures (radius or ulna or both)
  • Patients from 3 years to under 13 years, but the age limits depend on the biological development of the child and in addition

You may not qualify if:

  • multifragmentary fractures, metaphyseal and epiphyseal fractures
  • Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection, or where a patient's cooperation cannot be guaranteed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Landesklinikum Moedling

Mödling, Lower Austria, 2340, Austria

RECRUITING

Herlev and Gentofte University Hospital Department of Orthopedic Surgery

Herlev, 2730, Denmark

NOT YET RECRUITING

Hvidovre Hospital

Hvidovre, 2650, Denmark

NOT YET RECRUITING

Lille University Center, Jeanne de Flandre Hospital

Lille, 59000, France

NOT YET RECRUITING

University Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery

Lübeck, Schleswig-Holstein, 23538, Germany

NOT YET RECRUITING

Péterfy Hospital, National Trauma Center, Department of Pediatric Trauma Surgery

Budapest, Hungary

RECRUITING

Pécs University Hospital, Department of Pediatrics

Pécs, 7623, Hungary

NOT YET RECRUITING

Hospital Pediátrico - CHUC, EPE

Coimbra, 3000-602, Portugal

NOT YET RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, 1010, Switzerland

NOT YET RECRUITING

Related Publications (1)

  • Korhonen L, Perhomaa M, Kyro A, Pokka T, Serlo W, Merikanto J, Sinikumpu JJ. Intramedullary nailing of forearm shaft fractures by biodegradable compared with titanium nails: Results of a prospective randomized trial in children with at least two years of follow-up. Biomaterials. 2018 Dec;185:383-392. doi: 10.1016/j.biomaterials.2018.09.011. Epub 2018 Sep 11.

    PMID: 30292588BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Christoph Roeder, MD

    Landesklinikum Baden/Moedling

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Roeder, MD

CONTACT

+4322529004christoph.roeder@moedling.lknoe.at

Thomas Klestil, MD

CONTACT

+4322529004thomas.klestil@moedling.lknoe.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Univ.-Prof. DDr. Thomas Klestil

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 15, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

April 15, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)CH(1)AU(1)DE(1)DK(2)FR(1)HU(2)