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This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthrodesis | Active Comparator | Fusion |
|
| Cartiva | Experimental | Synthetic Cartilage Implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthrodesis | Device | arthrodesis using screws and/or a plate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| VAS, FAAM, Safety | The individual components of the primary outcome measures will be Visual Analog Scale (VAS) Pain, Foot and Ankle Ability Measure (FAAM) Sports sub-scale score and absence of key safety issues. | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Baumhauer | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada | ||
| University of Alberta |
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| Cartiva |
| Device |
Cartiva Synthetic Cartilage Implant |
|
| Edmonton |
| Alberta |
| Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Horizon Health Network | Fredericton | New Brunswick | E3B 5N5 | Canada |
| Queen Elizabeth Science Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5C 1R6 | Canada |
| Frimley Park Hospital - Surrey Foot and Ankle Clinic | Frimley | Camberley | GU16 7UJ | United Kingdom |
| St. George's Hospital | Tooting | London | SW17 0QT | United Kingdom |
| Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic | Stanmore | Middlesex | HA7 4LP | United Kingdom |
| Northern General Hospital NHS Trusts - Sheffield Orthopaedics | Sheffield | South Yorkshire | S5 7AU | United Kingdom |
| Royal Surrey County Hospital | Guildford | Surrey | GU2 5XX | United Kingdom |
| Torbay Hospital | South Devon | Torquay | TQ2 7AA | United Kingdom |
| 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 |
| D018409 | Foot Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001174 | Arthrodesis |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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