Clavicle Fracture
Conditions
Keywords
Clavicle fracture, Clavicle pin
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.
Interventions
DEVICEAnser 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.
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASES Score- 2 week | 2 weeks post-operation | American Shoulder and Elbow Surgeons Score |
| 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 |
| ASES Score- 1 year | 1 year 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- 6 week | 6 weeks post-operation | Disabilities of Arm, Shoulder and Hand Score |
| DASH Score- 3 month | 3 months post-operation | Disabilities of Arm, Shoulder and Hand Score |
| DASH Score- 1 year | 1 year post-operation | Disabilities of Arm, Shoulder and Hand 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 |
| Clinical union rate | 1 year post-operation | Clinical union is defined as the absence of pain over the fracture site upon palpation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Braman, MD
University of Minnesota
Outcome results
None listed