Wright Foot & Ankle Post-Market Observational Study
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Foot and Ankle Devices 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
Wright devices used in foot and ankle procedures
|
Outcome Measures
Primary Outcome Measures
- EuroQol (EQ-5D-5L). [1 year]
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'.
Secondary Outcome Measures
- Foot and Ankle Ability Measure (FAAM) [1 year]
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).
- Safety Assessment [1 year]
Identifying and reporting the safety of the implant in terms of complications and adverse events.
- Surgeon Survey [1 year]
Conducting a surgeon survey including radiographic assessment of fusion and consolidation time
- Patient Survey [1 year]
Conducting patient surveys to assess current implant status (to include complications)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Willing and able to consent to participate (written, informed consent);
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Willing and able to attend/complete the requested follow-up visits;
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Considered for treatment with one or more approved or cleared Wright Medical products included in this study
Exclusion Criteria:
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Subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated;
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Unable to consent to participate (written, informed consent);
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Unable to attend/complete the requested follow-up visits
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mercer-Bucks Orthopaedics | Hamilton | New Jersey | United States | 08691 |
| 2 | OrthoCarolina | Charlotte | North Carolina | United States | 28207 |
| 3 | CHRU Tours, Hôpital Trousseau | Tours | France | 37044 | |
| 4 | Hessingpark Clinic | Augsburg | Germany | ||
| 5 | Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust | Oswestry | Shropshire | United Kingdom |
Sponsors and Collaborators
- Stryker Trauma GmbH
Investigators
- Study Director: Rebecca Gibson, Stryker Nordic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INT19-MDR-001