Lower Extremity Fixation In Neuropathic Patients Study

Study Overview
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Brief Summary
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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, and/or VALOR™ NAIL of 200 patients with up to 10 sites

Detailed Description
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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, and/or VALOR™ NAIL of 200 patients with up to 10 sites.

Official Title
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Lower Extremity Fixation In Neuropathic Patients Study

Conditions
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Neuropathy, Charcot; Disease (Etiology)

Intervention / Treatment
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* Device: SALVATION™ EXTERNAL FIXATION


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to consent to participate (written, informed consent); Willing and able to attend/complete the requested follow-up visits; Considered for treatment for Neuropathy with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, and/or VALOR™ NAIL Exclusion Criteria: Subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated; Unable to consent to participate (written, informed consent); Unable to attend/complete the requested follow-up visits

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SALVATION™ EXTERNAL FIXATION|Wright Medical's lower extremity devices used to treat neuropathic patients|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Analysis of Implants at 3 years | 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 derived from a Kaplan-Meier survival analysis to a performance goal. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-5L | 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. The second part of the 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). | 5 years | 
| Foot and Ankle Ability Measure (FAAM) | 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 the FAAM and its component scores. The ADL and Sports subscales are scored separately. The scores for ADL can range from 0 to 84. The item score total is divided by the highest potential score. This value is then multiplied by 100 to get a percentage. A higher score represents a higher level of physical function. The scores for Sports subscale range from 0 to 32. The item score total is divided by the highest potential score. This value is then multiplied by 100 to get a percentage. A higher score represents a higher level of physical function. | 5 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 derived from a Kaplan-Meier survival analysis to a performance goal. | 5 years | 
| Radiographic Assessment | Assess fusion and consolidation time of bony unions utilizing surgeon's evaluations of standard of care x-rays | 5 years |