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Prematurely terminated -Sponsor decision not due to adverse events, complications, or device issues. Final data collection underway.
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A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integra® Cadence™ Total Ankle System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integra Cadence Total Ankle System | Device | Primary or revision on total ankle replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship | Implant survival defined as absence of device removal or revision. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline | Relative change of PROMIS PF - Mobility compared to baseline | up to 10 Years |
| Relative change of Range Of Motion (ROM) compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patients enrolled in this study will have will have at least one of the indications listed below and meet all of the inclusion criteria. Patients meeting any of the exclusion criteria are not eligible for this study. The Integra® Cadence™ Total Ankle System (CTAS) is indicated for use to treat:
The CTAS is also indicated for revision surgeries following failed total ankle replacement (TAR) and non-union/mal-union of ankle arthrodesis, provided sufficient bone stock is present.
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Daniels, MD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | San Francisco | California | 94118 | United States | ||
| Florida Orthopedic Foot and Ankle Center |
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Relative change of ROM compared to baseline |
| up to 10 Years |
| Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline | Relative change of FAAM compared to baseline | up to 10 Years |
| Relative change of Pain compared to baseline | Relative change of Visual Analogue Scale Pain compared to baseline | up to 10 Years |
| Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) | Relative change of SF-36v2 compared to baseline | up to 10 Years |
| Implant Survivorship | Implant survival defined as absence of device removal or revision. | 5 and 10 Years |
| Sarasota |
| Florida |
| 34239 |
| United States |
| State University of Ney York - Buffalo | Buffalo | New York | 14215 | United States |
| Duke University | Durham | North Carolina | 27703 | United States |
| OhioHealth Research Institute | Westerville | Ohio | 43082 | United States |
| Rothman Institute | Philadelphia | Pennsylvania | 49525 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Catholic Health Initiatives | Seattle | Washington | 98402 | United States |
| Calgary - South Health Campus | Calgary | Alberta | T3M 1M4 | Canada |
| Providence St. Joseph's and St. Michael's Healthcare | Toronto | Ontario | M5B 1W8 | Canada |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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