Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

Study Overview
=================
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.

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

Conditions
-----------------
Clavicle Fracture

Intervention / Treatment
-----------------
* Device: Anser Clavicle Pin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anser Clavicle Pin<br>Patients treated with Anser Clavicle Pin in the setting of a displaced midshaft clavicle fracture | Device: Anser Clavicle Pin<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clavicle fracture, Clavicle pin