Bioresorbable Intramedullary Nailing of Forearm Fractures

Not Applicable

Recruiting

• Conditions: Forearm Fracture
• Interventions: Other: MRI Scan

• Registration Number: NCT04846543
• Lead Sponsor: Thomas Klestil

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™.

Detailed Description

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.

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Last Update Submitted: 2021-04-13
• Study First Posted: 2021-04-15
• Last Update Posted: 2021-04-15
• Primary Completion: 2023-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI scan 1st and 2nd year	MRI Scan	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

Primary Outcome Measures

Name	Time	Method
Refracture rate	First year after operation	Assessment of refracture rate

Secondary Outcome Measures

Name	Time	Method
Absorption of implant	One and two years after operation	MRI scans are performed to evaluate soft tissue reaction and biodegradability
Bony union	One year after operation	Bony union depending on fracture type and immobilization time, return to sport
Monteggia lesion and equivalent	2 years after operation	Safety and performance of operative technique in Monteggia´s lesion
Cost effectiveness	1 year after operation	HTA assessment for different health care systems in Europe

Trial Locations

Locations (9)

Landesklinikum Moedling; 🇦🇹 Mödling, Lower Austria, Austria

Pécs University Hospital, Department of Pediatrics; 🇭🇺 Pécs, Hungary

Péterfy Hospital, National Trauma Center, Department of Pediatric Trauma Surgery; 🇭🇺 Budapest, Hungary

Hospital Pediátrico - CHUC, EPE; 🇵🇹 Coimbra, Portugal

Lille University Center, Jeanne de Flandre Hospital; 🇫🇷 Lille, France

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

University Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Herlev and Gentofte University Hospital Department of Orthopedic Surgery; 🇩🇰 Herlev, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark