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Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.
As part of the Conditions of Approval of Cartiva SCI for the treatment of first MTP osteoarthritis, the Food and Drug Administration (FDA) requires additional long term data to evaluate the long term safety and effectiveness of Cartiva including the durability and survivorship of the implant. This Post-Approval Study (PAS) addendum is intended to supplement the initial 24 months follow up period and provide additional long term safety and effectiveness data on Cartiva
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cartiva | Experimental | Cartiva Synthetic Cartilage Implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cartiva | Device | Cartiva Synthetic Cartilage Implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise |
| 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scale (VAS) | Visual Analog Scale (VAS) Pain | 5 year |
| Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) | Foot and Ankle Ability Measure (FAAM) Activities of Daily Living scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Baumhauer, MD | University of Rochester | Principal Investigator |
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| ID | Term |
|---|---|
| D020859 | Hallux Rigidus |
| D020857 | Hallux Limitus |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
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| 5 year |
| Foot and Ankle Ability Measure (FAAM) Sports | Foot and Ankle Ability Measure (FAAM) Sports scores | 5 year |
| D018409 |
| Foot Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |