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.
Study Type
OBSERVATIONAL
Enrollment
132
Primary or revision on total ankle replacement
Kaiser Permanente
San Francisco, California, United States
Florida Orthopedic Foot and Ankle Center
Sarasota, Florida, United States
State University of Ney York - Buffalo
Buffalo, New York, United States
Implant Survivorship
Implant survival defined as absence of device removal or revision.
Time frame: 2 years
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
Time frame: up to 10 Years
Relative change of Range Of Motion (ROM) compared to baseline
Relative change of ROM compared to baseline
Time frame: up to 10 Years
Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline
Relative change of FAAM compared to baseline
Time frame: up to 10 Years
Relative change of Pain compared to baseline
Relative change of Visual Analogue Scale Pain compared to baseline
Time frame: up to 10 Years
Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2)
Relative change of SF-36v2 compared to baseline
Time frame: up to 10 Years
Implant Survivorship
Implant survival defined as absence of device removal or revision.
Time frame: 5 and 10 Years
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Duke University
Durham, North Carolina, United States
OhioHealth Research Institute
Westerville, Ohio, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Catholic Health Initiatives
Seattle, Washington, United States
Calgary - South Health Campus
Calgary, Alberta, Canada
...and 1 more locations