ArthritisNCT04118894
Wright Foot & Ankle Post-Market Observational Study
An observational study of Arthritis and Rheumatoid Arthritis, run by Stryker Trauma and Extremities at 5 sites in 4 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid Arthritis, Fracture
- What is being tested?
- Foot and Ankle Devices
- Type of treatment
- Medical device
- How many people
- 119 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 22 Jan 2020to 12 Jul 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Instructions for Use (IFU) for each individual product can be found at http://www.wright.com/prescribing-use-3.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
OrthoCarolina
Charlotte, North Carolina, 28207
Mercer-Bucks Orthopaedics
Hamilton, New Jersey, 08691
United Kingdom1 site
Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire
About this study
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
Read the detailed 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.
- Conditions
- Arthritis, Rheumatoid Arthritis, Fracture, Trauma Injury, Fusion of Joint
- Being tested
- Foot and Ankle Devices
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Fractures, Bone, Accidental Injuries, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot and Ankle DevicesDevice
Wright devices used in foot and ankle procedures
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Foot and Ankle Devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 1 year
Secondary outcomes (4)
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).
Measured: 1 year
Safety Assessment
Identifying and reporting the safety of the implant in terms of complications and adverse events. (This is reported in the Adverse Event Section)
Measured: 1 year
Surgeon Survey
Conducting a surgeon survey including radiographic assessment of fusion and consolidation time
Measured: 1 year
Patient Survey
Conducting patient surveys to assess current implant status (to include complications)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start22 Jan 2020
- Primary completion8 Dec 2022
- Study completion12 Jul 2023
Why it stopped: Due to COVID the enrollment into the study was delayed. Sponsor chose to collect clinical data via alternative methods.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma and Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118894
- Sponsor's protocol ID
- INT19-MDR-001
- Status last verified
- Jan 2025
- First submitted
- 21 Aug 2019
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wright Foot & Ankle Post-Market Observational Study
- ClinicalTrials.gov ID
- NCT04118894
- Acronym / sponsor ID
- INT19-MDR-001
- Conditions
- Arthritis, Rheumatoid Arthritis, Fracture, Trauma Injury, Fusion of Joint
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to COVID the enrollment into the study was delayed. Sponsor chose to collect clinical data via alternative methods.
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foot and Ankle Devices | – | Device: Foot and Ankle DevicesThe study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Instructions for Use (IFU) for each individual product can be found at http://www.wright.com/prescribing-use-3.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot and Ankle DevicesWright devices used in foot and ankle procedures | Device | Foot and Ankle Devices |
Primary outcome
EuroQol (EQ-5D-5L).
Time frame: 1 year
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'.
4 secondary outcomes
Foot and Ankle Ability Measure (FAAM)
Time frame: 1 year
Safety Assessment
Time frame: 1 year
Surgeon Survey
Time frame: 1 year
Patient Survey
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Gibson study director
Stryker Trauma and Extremities
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Rheumatoid Arthritis, run by Stryker Trauma and Extremities at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, France, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQol (EQ-5D-5L). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.