Wright Foot & Ankle Post-Market Observational Study

Stryker Trauma and Extremities119 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

119

Conditions

Arthritis Rheumatoid Arthritis Fracture Trauma Injury Fusion of Joint

Interventions

Foot and Ankle DevicesDEVICE

Wright devices used in foot and ankle procedures

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

Mercer-Bucks Orthopaedics

Hamilton, New Jersey, United States

OrthoCarolina

Charlotte, North Carolina, United States

CHRU Tours, Hôpital Trousseau

Tours, France

Hessingpark Clinic

Augsburg, Germany

Outcomes

Primary Outcomes

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'.

Time frame: 1 year

Secondary Outcomes

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).

Time frame: 1 year

Safety Assessment

Identifying and reporting the safety of the implant in terms of complications and adverse events. (This is reported in the Adverse Event Section)

Time frame: 1 year

Surgeon Survey

Conducting a surgeon survey including radiographic assessment of fusion and consolidation time

Time frame: 1 year

Patient Survey

Conducting patient surveys to assess current implant status (to include complications)

Data from ClinicalTrials.gov

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