Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

Not Applicable

Suspended

• Conditions: Clavicle Fracture
• Interventions: Device: Anser Clavicle Pin

• Registration Number: NCT05454306
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25
• Study Start: 2028-01-09
• Primary Completion: 2030-01-09
• Study Completion: 2030-01-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
ASES Score- 1 year	1 year post-operation	American Shoulder and Elbow Surgeons Score
DASH Score- 6 week	6 weeks post-operation	Disabilities of Arm, Shoulder and Hand Score
ASES Score- 2 week	2 weeks post-operation	American Shoulder and Elbow Surgeons Score
Radiographic union rate	1 year post-operation	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
ASES Score- 6 week	6 weeks post-operation	American Shoulder and Elbow Surgeons Score
ASES Score- 3 month	3 months post-operation	American Shoulder and Elbow Surgeons Score
DASH Score- 2 week	2 weeks post-operation	Disabilities of Arm, Shoulder and Hand Score
DASH Score- 1 year	1 year post-operation	Disabilities of Arm, Shoulder and Hand Score
DASH Score- 3 month	3 months post-operation	Disabilities of Arm, Shoulder and Hand Score
Clinical union rate	1 year post-operation	Clinical union is defined as the absence of pain over the fracture site upon palpation.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States