Back to results

Bioresorbable Intramedullary Nailing of Forearm Fractures (BRINFF)

Primary Purpose

Forearm Fracture

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

MRI Scan

About this trial

This is an interventional treatment trial for Forearm Fracture

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Landesklinikum MoedlingRecruiting
Herlev and Gentofte University Hospital Department of Orthopedic Surgery
Hvidovre Hospital
Lille University Center, Jeanne de Flandre Hospital
University Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery
Péterfy Hospital, National Trauma Center, Department of Pediatric Trauma SurgeryRecruiting
Pécs University Hospital, Department of Pediatrics
Hospital Pediátrico - CHUC, EPE
Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRI scan 1st and 2nd year

Arm Description

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

Outcomes

Primary Outcome Measures

Refracture rate

Assessment of refracture rate

Secondary Outcome Measures

Absorption of implant

MRI scans are performed to evaluate soft tissue reaction and biodegradability

Bony union

Bony union depending on fracture type and immobilization time, return to sport

Monteggia lesion and equivalent

Safety and performance of operative technique in Monteggia´s lesion

Cost effectiveness

HTA assessment for different health care systems in Europe

Full Information

NCT ID

NCT04846543

First Posted

April 13, 2021

Last Updated

April 13, 2021

Sponsor

Thomas Klestil

Collaborators

Bioretec Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04846543

Brief Title

Bioresorbable Intramedullary Nailing of Forearm Fractures

Acronym

BRINFF

Official Title

PMCF Study - Verification of Activa IM-Nail™ Safety and Clinical Performance

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Thomas Klestil

Collaborators

Bioretec Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Forearm Fracture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MRI scan 1st and 2nd year

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

MRI Scan

Intervention Description

MRI scan

Primary Outcome Measure Information:

Title

Refracture rate

Description

Assessment of refracture rate

Time Frame

First year after operation

Secondary Outcome Measure Information:

Title

Absorption of implant

Description

MRI scans are performed to evaluate soft tissue reaction and biodegradability

Time Frame

One and two years after operation

Title

Bony union

Description

Bony union depending on fracture type and immobilization time, return to sport

Time Frame

One year after operation

Title

Monteggia lesion and equivalent

Description

Safety and performance of operative technique in Monteggia´s lesion

Time Frame

2 years after operation

Title

Cost effectiveness

Description

HTA assessment for different health care systems in Europe

Time Frame

1 year after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christoph Roeder, MD

Phone

+4322529004

Ext

27166

christoph.roeder@moedling.lknoe.at

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Klestil, MD

Phone

+4322529004

Ext

13201

thomas.klestil@moedling.lknoe.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Roeder, MD

Organizational Affiliation

Landesklinikum Baden/Moedling

Official's Role

Principal Investigator

Facility Information:

Facility Name

Landesklinikum Moedling

City

Mödling

State/Province

Lower Austria

ZIP/Postal Code

2340

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christoph Roeder, MD

Phone

+4322529004

Ext

27166

christoph.roeder@moedling.lknoe.at

First Name & Middle Initial & Last Name & Degree

Thomas Klestil, MD

Phone

+4322529004

Ext

13201

thomas.klestil@moedling.lknoe.at

Facility Name

Herlev and Gentofte University Hospital Department of Orthopedic Surgery

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Morten Andersen

Phone

+ 45 38 68 14 79

morten.jon.andersen@regionh.dk

Facility Name

Hvidovre Hospital

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Louise Klingenberg

Phone

0045 40884943

louise.klingenberg.03@regionh.dk

Facility Name

Lille University Center, Jeanne de Flandre Hospital

City

Lille

ZIP/Postal Code

59000

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Federico Canavese, Prof.

Phone

+33 3 20 44 68 67

federico.canavese@chru-lille.fr

Facility Name

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

City

Lübeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ludger Tüshaus

Phone

+49 451 500 42611

ludger.tueshaus@uksh.de

Facility Name

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

City

Budapest

Country

Hungary

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcell Varga

Phone

0036 79 932 30 27

drvmarcell@gmail.com

Facility Name

Pécs University Hospital, Department of Pediatrics

City

Pécs

ZIP/Postal Code

7623

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gergo Jozsa

Phone

+3672/535-900

dr.jozsa.gergo@gmail.com

Facility Name

Hospital Pediátrico - CHUC, EPE

City

Coimbra

ZIP/Postal Code

3000-602

Country

Portugal

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cristina Alves

Phone

+351239480355

6443@chuc.min-saude.pt

Facility Name

Centre Hospitalier Universitaire Vaudois

City

Lausanne

ZIP/Postal Code

1010

Country

Switzerland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas Lutz

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30292588

Citation

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.

Results Reference

background

Learn more about this trial

Bioresorbable Intramedullary Nailing of Forearm Fractures

We'll reach out to this number within 24 hrs