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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anser Clavicle Pin | Experimental | Patients treated with Anser Clavicle Pin in the setting of a displaced midshaft clavicle fracture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anser Clavicle Pin | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Braman, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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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 |