Wright Foot & Ankle Post-Market Observational Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04118894
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Wright Medical Technology
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Germany, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Rheumatoid Arthritis, Fracture, Trauma Injury, Fusion of Joint
Arms & Interventions

Arms

: Foot and Ankle Devices

Interventions

Device: - Foot and Ankle Devices

Wright devices used in foot and ankle procedures

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

OrthoCarolina, Charlotte, North Carolina

Status

Recruiting

Address

OrthoCarolina

Charlotte, North Carolina, 28207

International Sites

CHRU Tours, Hôpital Trousseau, Tours, France

Status

Recruiting

Address

CHRU Tours, Hôpital Trousseau

Tours, , 37044

Hessingpark Clinic, Augsburg, Germany

Status

Recruiting

Address

Hessingpark Clinic

Augsburg, ,

Oswestry, Shropshire, United Kingdom

Status

Recruiting

Address

Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire,