Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

NCT ID: NCT05454306

Last Updated: 2025-02-25

Study Results

Results pending

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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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2028-01-09

Study Completion Date

2030-01-09

Brief Summary

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The goals of this multi-site study are to evaluate the union rate, patient satisfaction, and functional results of the Section 510(K) approved Anser Clavicle Pin in a prospective 50 patient clinical trial in a U.S. population.

Detailed Description

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Conditions

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Clavicle Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Anser Clavicle Pin

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification
* Skeletally mature
* Surgery performed within 4 weeks after trauma

Exclusion Criteria

* Not fit for surgery by the anesthesiologist
* Nonunion or previous malunion
* Possible noncompliant patients (eg, alcohol and drug addiction, dementia)
* Additional neurovascular injury
* Pathologic fractures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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ORSU-2022-31047

Identifier Type: -

Identifier Source: org_study_id

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