Wright Foot & Ankle Post-Market Observational Study

Rheumatoid Arthritis Clinical Trial

Official title:

Wright Foot & Ankle Post-Market Observational Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04118894
• Other study ID #: INT19-MDR-001
• Status: Terminated
• Start date: January 22, 2020
• Est. completion date: May 12, 2023

Study information

• Verified date: January 2022
• Source: Stryker Trauma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: May 12, 2023
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Foot and Ankle Devices
Wright devices used in foot and ankle procedures

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Countries where clinical trial is conducted

United States,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Safety Assessment	Identifying and reporting the safety of the implant in terms of complications and adverse events.	1 year
Secondary	Surgeon Survey	Conducting a surgeon survey including radiographic assessment of fusion and consolidation time	1 year
Secondary	Patient Survey	Conducting patient surveys to assess current implant status (to include complications)	1 year