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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
University of Minnesota
Minneapolis, Minnesota, United States
ASES Score- 2 week
American Shoulder and Elbow Surgeons Score
Time frame: 2 weeks post-operation
ASES Score- 6 week
American Shoulder and Elbow Surgeons Score
Time frame: 6 weeks post-operation
ASES Score- 3 month
American Shoulder and Elbow Surgeons Score
Time frame: 3 months post-operation
ASES Score- 1 year
American Shoulder and Elbow Surgeons Score
Time frame: 1 year post-operation
DASH Score- 2 week
Disabilities of Arm, Shoulder and Hand Score
Time frame: 2 weeks post-operation
DASH Score- 6 week
Disabilities of Arm, Shoulder and Hand Score
Time frame: 6 weeks post-operation
DASH Score- 3 month
Disabilities of Arm, Shoulder and Hand Score
Time frame: 3 months post-operation
DASH Score- 1 year
Disabilities of Arm, Shoulder and Hand Score
Time frame: 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
Time frame: 1 year post-operation
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Clinical union rate
Clinical union is defined as the absence of pain over the fracture site upon palpation.
Time frame: 1 year post-operation