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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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The purpose of this research is to provide comparative data about the Avitus product and its equivalence to other Bone Marrow Aspirate (BMA) harvesting techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autograft Bone Harvest | Experimental | Patients undergoing an orthopedic foot and ankle surgery in which an autograft bone harvest will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avitus Bone Harvester | Device | Patients will receive standard of care treatment, in addition to one extra bone marrow sample obtained using the Avitus Bone Harvester. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of Cells Present | characterize what present cells can do | Until the end of the study (approximately 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular Component | Analysis of cellular components through counting, flow cytometry, and filtration of each sample type. | Until the end of the study (approximately 18 months) |
| Bone Growth Capacity |
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Inclusion Criteria:
Exclusion Criteria:
Patient is 70 yrs of age or older.
Patient is unwilling or unable to give consent or comply with study protocol.
Patient has any condition, which in the judgement of the Investigator, places the patient at undue risk or interferes with the study.
Patient has mental or neurological disorder that will not allow for proper informed consent.
Patient is known to be pregnant or breastfeeding.
Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
Patient has any condition, which in the judgement of the Investigator, may chemically skew bone marrow. This may include but is not limited to the following:
Patient presents with arthritis of the knee and may require knee replacement within the next 12 months.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward T Haupt, M.D. | Contact | 904-953-2496 | Haupt.Edward@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Edward T. Haupt, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Jacksonville | Florida | 32224 | United States |
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Analysis of the bone formation capacity of each sample type through measurement of growth factors and protein components.
| Until the end of study (approximately 18 months) |