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This is a phase IV post-marketing study for MagnetOs Putty and MagnetOs Easypack Putty. MagnetOs is a synthetic bone graft extender product that is routinely used by surgeon as treatment for hindfoot and ankle disorders.
In this study, MagnetOs Putty and MagnetOs Easypack Putty will be use according to the latest Instructions For Use, standalone in the foot and ankle.
In this study, following a screening period of a maximum of 45 days, approximately 126 patients will receive either MagnetOs Putty/Easypack Putty or autograft in conjunction with rigid hardware (arthrodesis) to treat hindfoot and ankle disorders. They will be randomized (1:1) into one of two treatment groups: standard rigid fixation with MagnetOs Putty/Easypack Putty or local autograft from the calcaneus, distal tibia, or proximal tibia.
They will be followed up at discharge at weeks 2, 6, 12, 24 and 52 post-surgery. The primary endpoint will be analyzed at 24 weeks post-op using CT-scan, and patients will continue follow-up for safety and efficacy for one year post operatively.
In this study, MagnetOs will be applied according to the IFU (Putty) approved in the US, Europe, Middle- East and Australia and Easypack Putty (approved in the US).
The surgical procedures studied in this clinical trial will include rigid hardware fixation and supplemental bone graft/substitute in the following procedures: ankle fusion (tibiotalar), subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, OR double fusion (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints. These procedures will be left to the investigator's discretion.
Radiographs images will be taken at screening, weeks 6, 12, 24 and 52; CT-scans will be taken at weeks 24 and 52 post-op If the patient has a secondary surgical intervention (procedure that adjusts or in any way modifies or removes part of the original implant configuration) at any time after the 6 month visit, the next CT scan will not be necessary. Starting at week 12, all XR images will be weight bearing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MagnetOs | Experimental | Interventions
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| Autograft | Active Comparator | Interventions
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagnetOs | Device | MagnetOs will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic fusion by CT scan | The primary endpoint is the incidence of fusion at each side by CT analysis as assessed by the independent radiological expert at 24 weeks post-op | Week 24 post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic fusion by CT scan | Joint fusion at Week 52 post-surgery assessed by CT-scans determined by an independent radiological expert panel (IREP) in patients undergoing hindfoot or ankle fusions | Week 52 |
| Radiographic Fusion by plain radiographs |
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Inclusion:
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cesar Silva, MD | Contact | 9702156793 | cesar.silva@kurosbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steadman Philippon Research Institute | Recruiting | Vail | Colorado | 81657 | United States |
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| Autograft | Other | In this study, the comparator is autograft and will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint. |
|
Joint fusion at Week 12, Week 24 and Week 52 post-surgery assessed by plain radiographs determined by an independent radiological expert panel (IREP) in patients undergoing hindfoot or ankle fusions |
| week 12, week 24, week 52 post-surgery |
| Functional | Change in Foot Function Index (FFI) from Screening to Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery. The score ranging from 0% to 100% indicates the severity of a person's foot issues. A score of 100% indicates worst possible pain, while 0% indicates no pain. | Screening to Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery. |
| Functional | Change in Visual Analog Score (VAS) from Screening to Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery. 0 no pain and 10 worst pain possible | Screening, Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery. |
| Functional | Change in SF-12 from Screening to Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery. Where 50 is the average health status for general U.S population. A score above 50 indicates better than average, while a score below 50 suggests below average health. | Screening, Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery. |
| Hughston Foundation Inc | Recruiting | Columbus | Georgia | 31909 | United States |
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| OrthoCarolina Research Institute, Inc | Recruiting | Charlotte | North Carolina | 28207 | United States |
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| Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Integrity Orthopedics and Sports Medicine | Recruiting | Chattanooga | Tennessee | 37404 | United States |
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| Centers for Advanced Orthopaedics | Recruiting | Falls Church | Virginia | 22042 | United States |
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| ID | Term |
|---|---|
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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