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| Name | Class |
|---|---|
| Bioretec Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI Scan | Other | MRI scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Refracture rate | Assessment of refracture rate | First year after operation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Roeder, MD | Contact | +4322529004 | 27166 | christoph.roeder@moedling.lknoe.at |
| Thomas Klestil, MD | Contact | +4322529004 | 13201 | thomas.klestil@moedling.lknoe.at |
| Name | Affiliation | Role |
|---|---|---|
| Christoph Roeder, MD | Landesklinikum Baden/Moedling | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landesklinikum Moedling | Recruiting | Mödling | Lower Austria | 2340 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30292588 | Background | 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. |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 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 |
| Herlev and Gentofte University Hospital Department of Orthopedic Surgery | Not yet recruiting | Herlev | 2730 | Denmark |
|
| Hvidovre Hospital | Not yet recruiting | Hvidovre | 2650 | Denmark |
|
| Lille University Center, Jeanne de Flandre Hospital | Not yet recruiting | Lille | 59000 | France |
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| University Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery | Not yet recruiting | Lübeck | Schleswig-Holstein | 23538 | Germany |
|
| Péterfy Hospital, National Trauma Center, Department of Pediatric Trauma Surgery | Recruiting | Budapest | Hungary |
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| Pécs University Hospital, Department of Pediatrics | Not yet recruiting | Pécs | 7623 | Hungary |
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| Hospital Pediátrico - CHUC, EPE | Not yet recruiting | Coimbra | 3000-602 | Portugal |
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| Centre Hospitalier Universitaire Vaudois | Not yet recruiting | Lausanne | 1010 | Switzerland |
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