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The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft with appropriate rigid internal fixation hardware as an alternative to autograft bone graft with rigid fixation in subtalar arthrodesis procedures. The primary objective of this clinical trial is to compare the overall fusion rate of the investigational to the control treatment. Fusion will be determined by clinical findings, radiographs and computed tomography (CT) of the subtalar joint 24 weeks (6 months) after the trial surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlloStem Live Cellular Allograft | Active Comparator | AlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone. |
|
| Control: Autologous Bone Marrow Aspirate | Active Comparator | Autologous bone graft is recovered from the patient's own tibia or iliac crest, for transplantation in the subtalar joint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subtalar Arthrodesis | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fusion Rate (%)(as determined by CT assessment) | Fusion Rate (%)(as determined by CT assessment) | 6 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic outcome assessments | Radiographic outcome assessments | Pre-operatively, 6 weeks, 3, 6, 12 and 24 months |
| Functional outcome measurements | FFI-R, SF-12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiaan Coetzee, MD | Minnesota Orthopedic Sports Medicine Institute (MOSMI) | Principal Investigator |
| Mark Myerson, MD | Institute for Foot and Ankle Reconstruction at Mercy | Principal Investigator |
| John Anderson, MD | Orthopaedic Associates of Michigan | Principal Investigator |
| Paul Juliano, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Andrew Murphy, MD | Campbell Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Foot and Ankle Reconstruction at Mercy | Baltimore | Maryland | 21202 | United States | ||
| Orthopaedic Associates of Michigan |
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| Pre-operatively, 6 weeks, 3, 6, 12 and 24 months |
| Functional outcome measurements | AOFAS | Pre-operatively, 3, 6, 12 and 24 months |
| Grand Rapids |
| Michigan |
| 49525 |
| United States |
| Minnesota Orthopedic Sports Medicine Institute (MOSMI) | Edina | Minnesota | 55435 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Campbell Clinic | Germantown | Tennessee | 38138 | United States |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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