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This is an Observational Device Registry Study of CERAMENT|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CERAMENT G | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcomes | • Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome | Bone healing at final follow-up | 12 months |
| Secondary Outcome | Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 & 12 months, if normally conducted |
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Inclusion Criteria:
Exclusion Criteria:
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The racial, gender and ethnic characteristics of the individuals approached for participation in this Observational Registry Study shall reflect the demographics of patients that would ordinarily receive CERAMENT|G for the treatment of their condition at the designated investigative centres. No individuals shall be excluded from participation in the Observational Registry Study based on race, nationality, ethnicity, gender, or sexuality
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian M Bartholdi | Contact | 16178923927 | brian.bartholdi@bonesupport.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Park Podiatry | Recruiting | San Diego | California | 92104 | United States |
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| 6 and 12 months |
| Secondary Outcome | (Recurrence of) infection/revision surgery | 12 months |
| OrthoCarolina | Recruiting | Charlotte | North Carolina | 28207 | United States |
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| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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