Wright Foot & Ankle Post-Market Observational Study

NCT ID: NCT04118894

Last Updated: 2025-01-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-22

Study Completion Date

2023-07-12

Brief Summary

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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

Detailed Description

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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.

Conditions

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Arthritis Rheumatoid Arthritis Fracture Trauma Injury Fusion of Joint

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Foot and Ankle Devices

Intervention Type DEVICE

Wright devices used in foot and ankle procedures

Interventions

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Foot and Ankle Devices

Wright devices used in foot and ankle procedures

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stryker Trauma and Extremities

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Gibson

Role: STUDY_DIRECTOR

Stryker Trauma and Extremities

Locations

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Mercer-Bucks Orthopaedics

Hamilton, New Jersey, United States

Site Status

OrthoCarolina

Charlotte, North Carolina, United States

Site Status

CHRU Tours, Hôpital Trousseau

Tours, , France

Site Status

Hessingpark Clinic

Augsburg, , Germany

Site Status

Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, United Kingdom

Site Status

Countries

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United States France Germany United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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INT19-MDR-001

Identifier Type: -

Identifier Source: org_study_id

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