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Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

NCT05454306 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-03-18

No results posted yet for this study

Summary

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.

Conditions

  • Clavicle Fracture

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jonathan Braman, MD · University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-01-09
Primary Completion
2030-01-09
Completion
2030-01-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05454306 on ClinicalTrials.gov