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Wright Foot & Ankle Post-Market Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118894
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Wright Medical Technology

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

Condition or disease Intervention/treatment
Arthritis Rheumatoid Arthritis Fracture Trauma Injury Fusion of Joint Device: Foot and Ankle Devices

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Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Wright Foot & Ankle Post-Market Observational Study
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Group/Cohort Intervention/treatment
Foot and Ankle Devices Device: Foot and Ankle Devices
Wright devices used in foot and ankle procedures




Primary Outcome Measures :
  1. Comparing the improvements in patient-reported pain and social interaction for quality of life from pre-op through post-operatively, assessed by the EuroQol (EQ-5D-5L). [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Comparing the improvement in patient-reported function scores from pre-op through post-operatively, assessed by the FAAM [ Time Frame: 1 year ]
  2. Identifying and reporting the safety of the implant in terms of complications and adverse events. [ Time Frame: 1 year ]
  3. Conducting a surgeon survey including radiographic assessment of fusion and consolidation time [ Time Frame: 1 year ]
  4. Conducting patient surveys to assess current implant status (to include complications) [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118894


Contacts
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Contact: Jennifer Seidman 901-310-1631 jennifer.seidman@wright.com
Contact: Robin Johnson 901-867-4783 robin.johnson@wright.com

Locations
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United States, North Carolina
OrthoCarolina Recruiting
Charlotte, North Carolina, United States, 28207
Principal Investigator: Todd Irwin, MD         
France
CHRU Tours, Hôpital Trousseau Recruiting
Tours, France, 37044
Principal Investigator: Jeran M Brilhault, Pr         
Germany
Hessingpark Clinic Recruiting
Augsburg, Germany
Principal Investigator: Manfred Thomas, Dr. Med         
Principal Investigator: Martin Jordan, Dr.Med         
Sponsors and Collaborators
Wright Medical Technology
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Responsible Party: Wright Medical Technology
ClinicalTrials.gov Identifier: NCT04118894    
Other Study ID Numbers: INT19-MDR-001
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases