Loading clinical trials...
Loading clinical trials...
PMCF Study - Verification of Activa IM-Nail™ Safety and Clinical Performance
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™.
Residual risk related to re-fracture rate will be addressed by this PMCF study. The research question is, if the re-fracture risk with Activa IM-nail is in line with the other treatment methods, namely ESIN. Primary objective: will be to assess clinical outcome by determining re-fracture rate of all treated patients, difference of re-fracture rate depending on the fracture type determined by X-ray (e.g. greenstick vs. non-greenstick fracture), subject's age, BMI, surgical technique, immobilization time and bony union formation.
Age
3 - 12 years
Sex
ALL
Healthy Volunteers
No
Landesklinikum Moedling
Mödling, Lower Austria, Austria
Herlev and Gentofte University Hospital Department of Orthopedic Surgery
Herlev, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Lille University Center, Jeanne de Flandre Hospital
Lille, France
University Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery
Lübeck, Schleswig-Holstein, Germany
Péterfy Hospital, National Trauma Center, Department of Pediatric Trauma Surgery
Budapest, Hungary
Pécs University Hospital, Department of Pediatrics
Pécs, Hungary
Hospital Pediátrico - CHUC, EPE
Coimbra, Portugal
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Start Date
March 1, 2021
Primary Completion Date
September 1, 2023
Completion Date
September 1, 2024
Last Updated
April 15, 2021
220
ESTIMATED participants
MRI Scan
OTHER
Lead Sponsor
Thomas Klestil
Collaborators
NCT06078371
NCT06658379
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions