Wright Foot & Ankle Post-Market Observational Study

NCT04118894 | Terminated Results FDA Device

• 1 other identifier: INT19-MDR-001
• Study Type: observational
• Target: 119
• Locations: 4 countries
• Sites: 5

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

Conditions

Arthritis; Rheumatoid Arthritis; Fracture; Trauma Injury; Fusion of Joint

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Foot and Ankle Ability Measure (FAAM)

  1 year

• Safety Assessment

  1 year

• Surgeon Survey

  1 year

• Patient Survey

  1 year

Study Arms (1)

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

Interventions

Foot and Ankle Devices DEVICE

Wright devices used in foot and ankle procedures

Foot and Ankle Devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (5)

Mercer-Bucks Orthopaedics

Hamilton, New Jersey, 08691, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

CHRU Tours, Hôpital Trousseau

Tours, 37044, France

Location

Hessingpark Clinic

Augsburg, Germany

Location

Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, United Kingdom

Location

MeSH Terms

Conditions

Arthritis; Arthritis, Rheumatoid; Fractures, Bone; Accidental Injuries; Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Wounds and Injuries

Results Point of Contact

• Title: Jennifer Seidman, Manager, Clinical Research
• Organization: Stryker

jennifer.seidman@stryker.com

9016338616

Study Officials

• Rebecca Gibson

  Stryker Trauma and Extremities

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: October 8, 2019
• Study Start: January 22, 2020
• Primary Completion: December 8, 2022
• Study Completion: July 12, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); DE (1); FR (1); GB (1)