Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

The Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures; A U.S. Prospective Case Series

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.

Study Overview

• Status: Withdrawn
• Conditions: Clavicle Fracture
• Intervention / Treatment: Device: Anser Clavicle Pin

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES Score- 2 week	American Shoulder and Elbow Surgeons Score	2 weeks post-operation
ASES Score- 6 week	American Shoulder and Elbow Surgeons Score	6 weeks post-operation
ASES Score- 3 month	American Shoulder and Elbow Surgeons Score	3 months post-operation
ASES Score- 1 year	American Shoulder and Elbow Surgeons Score	1 year post-operation
DASH Score- 2 week	Disabilities of Arm, Shoulder and Hand Score	2 weeks post-operation
DASH Score- 6 week	Disabilities of Arm, Shoulder and Hand Score	6 weeks post-operation
DASH Score- 3 month	Disabilities of Arm, Shoulder and Hand Score	3 months post-operation
DASH Score- 1 year	Disabilities of Arm, Shoulder and Hand Score	1 year post-operation
Radiographic union rate	Radiographic union is defined as a 2/3rd circumferential cortical bridging between medial and lateral fragments on both radiographs as determined by the treating surgeon and an independent radiologist	1 year post-operation
Clinical union rate	Clinical union is defined as the absence of pain over the fracture site upon palpation.	1 year post-operation

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jonathan Braman, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): January 9, 2028
• Primary Completion (Estimated): January 9, 2030
• Study Completion (Estimated): January 9, 2030

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Clavicle fracture; Clavicle pin
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: ORSU-2022-31047

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No