Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures
NCT ID: NCT05454306
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
50 participants
INTERVENTIONAL
2028-01-09
2030-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Anser Clavicle Pin
Patients treated with Anser Clavicle Pin in the setting of a displaced midshaft clavicle fracture
Anser Clavicle Pin
The Anser Clavicle Pin is an intramedullary device that has been studied in 20 patients in an EU-based prospective case series.28 A 100% union rate was found. The Constant-Murley score at 1-year was 96.7 (SD 5). The Disabilities of Arm, Shoulder and Hand score was 5.1 (SD 10). There were no infections, neuropathy of the supraclavicular nerve or hardware irritation requiring removal of hardware. Three device-related complications (15%) occurred including plastic deformation, protrusion and hardware failure. VAS satisfaction was 8.9 (SD 1) at the 1-year follow up.
Interventions
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Anser Clavicle Pin
The Anser Clavicle Pin is an intramedullary device that has been studied in 20 patients in an EU-based prospective case series.28 A 100% union rate was found. The Constant-Murley score at 1-year was 96.7 (SD 5). The Disabilities of Arm, Shoulder and Hand score was 5.1 (SD 10). There were no infections, neuropathy of the supraclavicular nerve or hardware irritation requiring removal of hardware. Three device-related complications (15%) occurred including plastic deformation, protrusion and hardware failure. VAS satisfaction was 8.9 (SD 1) at the 1-year follow up.
Eligibility Criteria
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Inclusion Criteria
* Skeletally mature
* Surgery performed within 4 weeks after trauma
Exclusion Criteria
* Nonunion or previous malunion
* Possible noncompliant patients (eg, alcohol and drug addiction, dementia)
* Additional neurovascular injury
* Pathologic fractures
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Jonathan Braman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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ORSU-2022-31047
Identifier Type: -
Identifier Source: org_study_id
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