Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

Clavicle Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05454306
• Other study ID #: ORSU-2022-31047
• Status: Suspended
• Phase: N/A
• Start date: January 9, 2028
• Est. completion date: January 9, 2030

Study information

• Verified date: March 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: January 9, 2030
• Est. primary completion date: January 9, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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