Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

University of Minnesota (UMN)

Status: Suspended

Conditions: Clavicle Fracture

Treatments: Device: Anser Clavicle Pin

Study type: Interventional

Funder types: Other

Identifiers

NCT05454306

ORSU-2022-31047

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Anser Clavicle Pin

Experimental group

Description:

Patients treated with Anser Clavicle Pin in the setting of a displaced midshaft clavicle fracture

Treatment:

Device: Anser Clavicle Pin