Wright Foot & Ankle Post-Market Observational Study

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

Study Overview

• Status: Terminated
• Conditions: Arthritis; Rheumatoid Arthritis; Trauma Injury; Fracture; Fusion of Joint
• Intervention / Treatment: Device: Foot and Ankle Devices

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 Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • CHRU Tours, Hôpital Trousseau
• Germany
  • Augsburg, Germany
    • Hessingpark Clinic
• United Kingdom
  • Shropshire
    • Oswestry, Shropshire, United Kingdom
      • Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
• United States
  • New Jersey
    • Hamilton, New Jersey, United States, 08691
      • Mercer-Bucks Orthopaedics
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The Instructions for Use (IFU) for each individual product can be found at http://www.wright.com/prescribing-use-3.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH
• Investigators: Study Director: Rebecca Gibson, Stryker Nordic

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): July 7, 2022
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: INT19-MDR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes