Trials Sponsors Conditions Drugs Pricing

Conditions

Arthritis Fracture Fusion of Joint Rheumatoid Arthritis Trauma Injury

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 DevicesDevice

Wright devices used in foot and ankle procedures

Foot and Ankle Devices

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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);

Sponsors & Collaborators

Stryker Trauma and Extremities
Industrylead

Study Sites (5)

Mercer-Bucks Orthopaedics

Hamilton, New Jersey, 08691, United States

OrthoCarolina

Charlotte, North Carolina, 28207, United States

CHRU Tours, Hôpital Trousseau

Tours, 37044, France

Hessingpark Clinic

Augsburg, Germany

Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, United Kingdom

MeSH Terms

Conditions

ArthritisArthritis, RheumatoidFractures, BoneAccidental InjuriesAnkylosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesWounds and Injuries

Results Point of Contact

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

Study Officials

Rebecca Gibson
Stryker Trauma and Extremities
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

119 participants (actual enrollment reported by the registry).

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

Actual (reported)

Study Stopped

Wright Foot & Ankle Post-Market Observational Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Foot and Ankle Devices

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Foot and Ankle Devices

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations