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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24145
Enrollment
20
Registered
2016-09-30
Start date
2016-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clavicle Fractures

Interventions

Use of the Anser Clavicle Pin for midshaft clavicle fractures.

Sponsors

Radboud UMC Nijmegen
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: • All patients deemed not fit for surgery by the anesthesiologist • All patients with nonunion or previous malunion • Patients 65 years • Possible noncompliant patients (eg, alcohol and drug addiction, dementia) • Additional neurovascular injury • Pathologic fractures

Design outcomes

Primary

MeasureTime frame
The primary outcome measures will be union rate, complication rate and functional outcome scores.

Secondary

MeasureTime frame
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.

Contacts

Public ContactPaul Hoogervorst
paul.hoogervorst@radboudumc.nl024-3614148

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)