Wright Foot & Ankle Post-Market Observational Study

Study Overview
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Brief Summary
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WRIGHT FOOT & ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device

Detailed Description
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The selected design is a global, multi-center, non-randomized, prospective observational study. The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.

Official Title
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Wright Foot & Ankle Post-Market Observational Study

Conditions
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Arthritis, Rheumatoid Arthritis, Fracture, Trauma Injury, Fusion of Joint

Intervention / Treatment
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* Device: Foot and Ankle Devices


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 with one or more approved or cleared Wright Medical products included in this study 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: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Foot and Ankle Devices<br>The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study. | Device: Foot and Ankle Devices<br>* Wright devices used in foot and ankle procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQol (EQ-5D-5L). | Comparing the changes in patient-reported pain and social interaction for quality of life from pre-op through post-operatively, assessed by the EuroQol (EQ-5D-5L). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. Health utility values generated from the EQ-5D generally range from 0 (death) to 1 (perfect health). But health utility values less than 0 are possible, and represent health states considered worse than death. The EQ VAS records the patient's self-rated health on a VAS (0-100), where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot and Ankle Ability Measure (FAAM) | Comparing the changes in patient-reported function scores from pre-op through post-operatively, assessed by the FAAM The FAAM is a patient-completed instrument that consists of an Activities of Daily Living subscale (21 scored items) and a Sports subscale (7 scored items) in which the response options are presented as 5-point Likert scales (range 4 to 0). Scores for each subscale range from 0% (least function) to 100% (most function). | 1 year | 
| Safety Assessment | Identifying and reporting the safety of the implant in terms of complications and adverse events. | 1 year | 
| Surgeon Survey | Conducting a surgeon survey including radiographic assessment of fusion and consolidation time | 1 year | 
| Patient Survey | Conducting patient surveys to assess current implant status (to include complications) | 1 year |