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| Name | Class |
|---|---|
| MCRA | INDUSTRY |
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This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections. The study is expected to take approximately 18 months from first subject enrolled to the last follow-up visit. It will have a 12-month enrollment period and a 6-month follow-up. This study is a Prospective, multicenter, single-arm clinical trial. All subjects enrolled in this study will receive the REMEDY SPECTRUM IM Spacer Nail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with REMEDY Spectrum IM Spacer Nail | Experimental | This is the REMEDY Spectrum IM Spacer Nail treatment group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REMEDY Spectrum IM Spacer Nail | Combination Product | The REMEDY SPECTRUM IM Spacer Nail is a single-use implant made of polymethylmethacrylate (PMMA) which is internally reinforced with a stainless-steel core (ASTM F138, ISO 5832-1). The PMMA of the REMEDY SPECTRUM IM Spacer Nail is laden with gentamicin and vancomycin. The nail has a slot at the distal end and can be combined with the surgeon's choice of fixation to prevent migration depending on the anatomy of the patient. The REMEDY SPECTRUM IM Spacer Nail is available in two lengths (150mm and 300mm) to accommodate variations in patient anatomy. The distal end has a threaded recess for mating with the optional distal cap, as well as the insertion and removal tools. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Treatment of Infection Based on Lab Values and Culture | Healed wound and no infection recurrence caused by the same organism strain infection for duration of two weeks post antibiotic regimen. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Crystal Djaba | Contact | 470-736-7850 | cdjaba@mcra.com | |
| Jacob Schafer | Contact | jschafer@mcra.com |
| Name | Affiliation | Role |
|---|---|---|
| Rachel McGuire Kennedy | OsteoRemedies, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health - Sparrow Clinical Research Institute | Recruiting | Lansing | Michigan | 48190 | United States |
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| OrthoCarolina Research Institute | Recruiting | Charlotte | North Carolina | 28207 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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