Bioresorbable Intramedullary Nailing of Forearm Fractures (BRINFF)

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™.

Study Overview

• Status: Recruiting
• Conditions: Forearm Fracture
• Intervention / Treatment: Other: MRI Scan

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 Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoph Roeder, MD; Phone Number: 27166 +4322529004; Email: christoph.roeder@moedling.lknoe.at
• Study Contact Backup: Name: Thomas Klestil, MD; Phone Number: 13201 +4322529004; Email: thomas.klestil@moedling.lknoe.at

Study Locations

• Austria
  • Lower Austria
    • Mödling, Lower Austria, Austria, 2340
      • Recruiting
      • Landesklinikum Moedling
      • Contact: Christoph Roeder, MD; Phone Number: 27166 +4322529004; Email: christoph.roeder@moedling.lknoe.at
      • Contact: Thomas Klestil, MD; Phone Number: 13201 +4322529004; Email: thomas.klestil@moedling.lknoe.at
• Denmark
  • Herlev, Denmark, 2730
    • Not yet recruiting
    • Herlev and Gentofte University Hospital Department of Orthopedic Surgery
    • Contact: Morten Andersen; Phone Number: + 45 38 68 14 79; Email: morten.jon.andersen@regionh.dk
  • Hvidovre, Denmark, 2650
    • Not yet recruiting
    • Hvidovre Hospital
    • Contact: Louise Klingenberg; Phone Number: 0045 40884943; Email: louise.klingenberg.03@regionh.dk
• France
  • Lille, France, 59000
    • Not yet recruiting
    • Lille University Center, Jeanne de Flandre Hospital
    • Contact: Federico Canavese, Prof.; Phone Number: +33 3 20 44 68 67; Email: federico.canavese@chru-lille.fr
• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Not yet recruiting
      • University Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery
      • Contact: Ludger Tüshaus; Phone Number: +49 451 500 42611; Email: ludger.tueshaus@uksh.de
• Hungary
  • Budapest, Hungary
    • Recruiting
    • Péterfy Hospital, National Trauma Center, Department of Pediatric Trauma Surgery
    • Contact: Marcell Varga; Phone Number: 0036 79 932 30 27; Email: drvmarcell@gmail.com
  • Pécs, Hungary, 7623
    • Not yet recruiting
    • Pécs University Hospital, Department of Pediatrics
    • Contact: Gergo Jozsa; Phone Number: +3672/535-900; Email: dr.jozsa.gergo@gmail.com
• Portugal
  • Coimbra, Portugal, 3000-602
    • Not yet recruiting
    • Hospital Pediátrico - CHUC, EPE
    • Contact: Cristina Alves; Phone Number: +351239480355; Email: 6443@chuc.min-saude.pt
• Switzerland
  • Lausanne, Switzerland, 1010
    • Not yet recruiting
    • Centre Hospitalier Universitaire Vaudois
    • Contact: Nicolas Lutz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MRI scan 1st and 2nd year; 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; MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refracture rate	Assessment of refracture rate	First year after operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Klestil
• Collaborators: Bioretec Ltd.
• Investigators: Principal Investigator: Christoph Roeder, MD, Landesklinikum Baden/Moedling

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: DanubeUK3031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No