The goals of this study are to evaluate the initial performance, safety and functional results of the Anser; A novel intramedullary device for fixation of midshaft clavicle fractures.
ID
Bron
Verkorte titel
Aandoening
Clavicle Fractures
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measures will be union rate, complication rate and functional outcome scores.
Achtergrond van het onderzoek
The Anser is a novel device for the intramedullary fixation of the fractured clavicle aiming to reduce the clavicle and preserve its length in a minimally invasive manner.
The goals of this study are to evaluate the initial performance, safety and functional results of the Anser; A novel intramedullary device for fixation of midshaft clavicle fractures.
The primary outcome measures will be union rate, complication rate and functional outcome scores.
Secondary outcomes will be closed reduction rate, operative time, image-intensifier time, hospital stay, incision length, time to radiological union, pain, re-operation, health related quality of life and cosmetic satisfaction.
Prospective explorative case series. Therapeutic study. 3 Dutch hospitals are involved.
20 patients between 18 and 65 years of age with a displaced midshaft clavicle fracture type 2A2 or 2B1 according to the Robinson Classification are included once informed consent is given. Follow up will be 12 months.
Doel van het onderzoek
The goals of this study are to evaluate the initial performance, safety and functional results of the Anser; A novel intramedullary device for fixation of midshaft clavicle fractures.
Onderzoeksopzet
-
Onderzoeksproduct en/of interventie
Use of the Anser Clavicle Pin for midshaft clavicle fractures.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Displaced midshaft clavicle fracture Type 2A2 or 2B1 according to the Robinson Classification
• Age > 18 years, < 65 years
• < 10 days after trauma
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• All patients deemed not fit for surgery by the anesthesiologist
• All patients with nonunion or previous malunion
• Patients <18 years or > 65 years
• Possible noncompliant patients (eg, alcohol and drug addiction, dementia)
• Additional neurovascular injury
• Pathologic fractures
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6097 |
| NTR-old | NTR6243 |
| Ander register | CMO Arnhem-Nijmegen : 2016-2428 |