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This post-market clinical study is being done to evaluate the use of the NovaLignâ„¢ Intramedullary Fixation System in the treatment of humeral fractures.
This is an observational, prospective, nonrandomized open label, post-market clinical study, designed to evaluate the use a flexible intramedullary fixation device used in the treatment of fractures of the humerus. This is a multicentre trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramedullary Fixation System | Experimental | Humeral fractures to be treated with the Intramedullary Fixation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovaLign Intramedullary Fixation System | Device | Intramedullary fixation of broken humerus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic union and safety | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Function, pain, and quality of life assessments at regular intervals | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| B Crist, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health Medical Center | Recruiting | Denver | Colorado | 80204 | United States |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| University of Missouri - Columbia | Recruiting | Columbia | Missouri | 65212 | United States |
|