Forearm FractureBRINFFNCT04846543
Bioresorbable Intramedullary Nailing of Forearm Fractures
A study testing MRI Scan in people with Forearm Fracture, run by Thomas Klestil at 9 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Forearm Fracture
- What is being tested?
- MRI Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 1 Mar 2021to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
Denmark2 sites, 2 recruiting
- Not yet recruiting
Herlev and Gentofte University Hospital Department of Orthopedic Surgery
Herlev, 2730
Morten Andersen, + 45 38 68 14 79, morten.jon.andersen@regionh.dk
- Not yet recruiting
Hvidovre Hospital
Hvidovre, 2650
Louise Klingenberg, 0045 40884943, louise.klingenberg.03@regionh.dk
Hungary2 sites, 2 recruiting
- Recruiting
Péterfy Hospital, National Trauma Center, Department of Pediatric Trauma Surgery
Budapest
Marcell Varga, 0036 79 932 30 27, drvmarcell@gmail.com
- Not yet recruiting
Pécs University Hospital, Department of Pediatrics
Pécs, 7623
Gergo Jozsa, +3672/535-900, dr.jozsa.gergo@gmail.com
Austria1 site, 1 recruiting
- Recruiting
Landesklinikum Moedling
Mödling, Lower Austria, 2340
Christoph Roeder, MD, +4322529004 ext. 27166, christoph.roeder@moedling.lknoe.at
Thomas Klestil, MD, +4322529004 ext. 13201, thomas.klestil@moedling.lknoe.at
France1 site, 1 recruiting
- Not yet recruiting
Lille University Center, Jeanne de Flandre Hospital
Lille, 59000
Federico Canavese, Prof., +33 3 20 44 68 67, federico.canavese@chru-lille.fr
Germany1 site, 1 recruiting
- Not yet recruiting
University Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery
Lübeck, Schleswig-Holstein, 23538
Ludger Tüshaus, +49 451 500 42611, ludger.tueshaus@uksh.de
Portugal1 site, 1 recruiting
- Not yet recruiting
Hospital Pediátrico - CHUC, EPE
Coimbra, 3000-602
Cristina Alves, +351239480355, 6443@chuc.min-saude.pt
Switzerland1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1010
Nicolas Lutz
About this study
Official title: 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™.
Read the 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.
- Conditions
- Forearm Fracture
- Being tested
- MRI Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ScanOther
MRI scan
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refracture rate
Assessment of refracture rate
Measured: First year after operation
Secondary outcomes (4)
Absorption of implant
MRI scans are performed to evaluate soft tissue reaction and biodegradability
Measured: One and two years after operation
Bony union
Bony union depending on fracture type and immobilization time, return to sport
Measured: One year after operation
Monteggia lesion and equivalent
Safety and performance of operative technique in Monteggia´s lesion
Measured: 2 years after operation
Cost effectiveness
HTA assessment for different health care systems in Europe
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Mar 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Forearm FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Klestil
- Sponsor type
- University, hospital or other
- Collaborators
- Bioretec Ltd.
- Responsible party
- Sponsor-investigator, Thomas Klestil, Danube University Krems
- Investigators
- Christoph Roeder, MD, Principal investigator, Landesklinikum Baden/Moedling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846543
- Sponsor's protocol ID
- DanubeUK3031
- Acronym
- BRINFF
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30292588
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMCF Study - Verification of Activa IM-Nail™ Safety and Clinical Performance
- ClinicalTrials.gov ID
- NCT04846543
- Acronym / sponsor ID
- BRINFF / DanubeUK3031
- Conditions
- Forearm Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Thomas KlestilUniversity, hospital or other
- Collaborators
- Bioretec Ltd.
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI scan 1st and 2nd year | Other | Other: MRI ScanAdditionally to routinely follow up, there will be an MRI scan of enrolled patients after one and two years in some of the study sites |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI ScanMRI scan | Other | MRI scan 1st and 2nd year |
Primary outcome
Refracture rate
Time frame: First year after operation
Assessment of refracture rate
4 secondary outcomes
Absorption of implant
Time frame: One and two years after operation
Bony union
Time frame: One year after operation
Monteggia lesion and equivalent
Time frame: 2 years after operation
Cost effectiveness
Time frame: 1 year after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Background: PubMed 30292588Korhonen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Roeder, MD principal investigator
Landesklinikum Baden/Moedling
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Scan in people with Forearm Fracture, run by Thomas Klestil at 9 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark, Hungary, Austria, France, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Roeder, MD (+4322529004 ext. 27166, christoph.roeder@moedling.lknoe.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refracture rate (time frame: First year after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.