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Initial results of the Anser: A novel intramedullary device for fixation of midshaft clavicle fractures.
An explorative case series



- candidate number25345
- NTR NumberNTR6243
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-sep-2016
- Secondary IDs2016-2428 CMO Arnhem-Nijmegen
- Public TitleInitial results of the Anser: A novel intramedullary device for fixation of midshaft clavicle fractures.
An explorative case series
- Scientific TitleInitial results of the Anser: A novel intramedullary device for fixation of midshaft clavicle fractures.
An explorative case series
- ACRONYMAnser Trial
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedClavicula, Fracture
- Inclusion criteria Displaced midshaft clavicle fracture Type 2A2 or 2B1 according to the Robinson Classification
Age > 18 years, < 65 years
< 10 days after trauma
- Exclusion criteria 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-nov-2016
- planned closingdate1-mei-2018
- Target number of participants20
- InterventionsUse of the Anser Clavicle Pin for midshaft clavicle fractures.
- Primary outcomeThe primary outcome measures will be union rate, complication rate and functional outcome scores.
- Secondary outcomeSecondary 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.
- Timepoints-
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Paul Hoogervorst
- CONTACT for SCIENTIFIC QUERIES Paul Hoogervorst
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
STW/NWO
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD30-sep-2016 - 29-apr-2017


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