Rheumatoid Arthritis Clinical Trial
Official title:
Wright Foot & Ankle Post-Market Observational Study
Verified date | January 2022 |
Source | Stryker Trauma GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Terminated |
Enrollment | 125 |
Est. completion date | May 12, 2023 |
Est. primary completion date | July 7, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU Tours, Hôpital Trousseau | Tours | |
Germany | Hessingpark Clinic | Augsburg | |
United Kingdom | Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust | Oswestry | Shropshire |
United States | OrthoCarolina | Charlotte | North Carolina |
United States | Mercer-Bucks Orthopaedics | Hamilton | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Stryker Trauma GmbH |
United States, France, Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Safety Assessment | Identifying and reporting the safety of the implant in terms of complications and adverse events. | 1 year | |
Secondary | Surgeon Survey | Conducting a surgeon survey including radiographic assessment of fusion and consolidation time | 1 year | |
Secondary | Patient Survey | Conducting patient surveys to assess current implant status (to include complications) | 1 year |
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