Prospective, multi-site, multi-year post-market clinical follow-up study on neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites
The selected design is a US, multi-center, multi-year, non-randomized, prospective observational study. The study subjects included are neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites.
Study Type
OBSERVATIONAL
Enrollment
45
Wright Medical's lower extremity devices used to treat neuropathic patients
Florida Joint Care Institute
Trinity, Florida, United States
Premier Orthopaedic and Sports Medicine
West Chester, Pennsylvania, United States
Central Tennessee Foot and Ankle Center
Sparta, Tennessee, United States
Survival Analysis of Implants at 1 Year
Compare the pooled cumulative 3-year amputation (above or below the knee) rate of neuropathic patients implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM derived from a Kaplan-Meier survival analysis to a performance goal.
Time frame: 1 years
EQ-5D-5L- Index
Evaluate improvements in patient-reported pain, function, and social interaction for quality of life from pre-op through each annual visit as assessed by the EQ-5D-5L and its component scores. Health state index scores generally range from less than 0 to 1 with higher scores indicating higher health utility. The health state preferences often represent national or regional values and can therefore differ between countries/regions.
Time frame: 1 year
FAAM-ADL
The FAAM has been shown to be valid and responsive in assessing diabetic foot disease and includes 2 subscales: Activities of Daily Living (ADL) Subscale (21 items) and Sports Subscale (8 items). For each subscale patients are asked to answer each question with a single response that most clearly describes their condition within the past week: no difficulty (4 points), slight difficulty (3 points), moderate difficulty (2 points), extreme difficulty (1 point), and unable to do (0 points). To calculate the score for either subscale, the total number of points are added (84 for the ADL subscale and 32 for the sports subscale) and converted to a percentage. A higher score reflects a higher level of physical function.
Time frame: 1 years
Survival Analysis of Implants at 5 Years
Compare the pooled cumulative 5-year amputation (above or below the knee) rate of neuropathic patients implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM derived from a Kaplan-Meier survival analysis to a performance goal.
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Time frame: 5 years
Radiographic Assessment
Assess fusion and consolidation time of bony unions utilizing surgeon's evaluations of standard of care x-rays
Time frame: 5 years
EQ-5D-5L-VAS
The second part of the EQ-5D-5L questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Time frame: 1 Year