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NCT04118894

Wright Foot & Ankle Post-Market Observational Study

Terminated Results posted Last updated 14 January 2025
What this trial tests

trial testing Foot and Ankle Devices in Arthritis in 119 participants. Terminated before completion.

Timeline
22 January 2020
Primary endpoint
8 December 2022
12 July 2023

Quick facts

Lead sponsorStryker Trauma and Extremities
StatusTerminated
Study typeOBSERVATIONAL
Enrollment119
Start date22 January 2020
Primary completion8 December 2022
Estimated completion12 July 2023
Sites5 locations across France, United Kingdom, United States, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Stryker Trauma and Extremities — full company profile →

Who can join

18 and older, any sex, with Arthritis or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

EuroQol (EQ-5D-5L). Primary · 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 he

GroupValue95% CI
Foot and Ankle Devices74.1± 22.5
Foot and Ankle Ability Measure (FAAM) Secondary · 1 year

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).

GroupValue95% CI
Foot and Ankle Devices68.6± 25.5
Safety Assessment Secondary · 1 year

Identifying and reporting the safety of the implant in terms of complications and adverse events. (This is reported in the Adverse Event Section)

GroupValue95% CI
Foot and Ankle Devices9
Foot and Ankle Devices110
Surgeon Survey Secondary · 1 year

Conducting a surgeon survey including radiographic assessment of fusion and consolidation time

GroupValue95% CI
Foot and Ankle Devices109
Foot and Ankle Devices3
Patient Survey Secondary · 1 year

Conducting patient surveys to assess current implant status (to include complications)

Experienced any complications associated with your procedure requiring you to seek medical care?
GroupValue95% CI
Foot and Ankle Devices7
Foot and Ankle Devices42
Any surgery to remove any device parts associated with your foot/ankle procedure?
GroupValue95% CI
Foot and Ankle Devices1
Foot and Ankle Devices48

Adverse events — posted to ClinicalTrials.gov

Time frame: Surgery to 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Foot and Ankle Devices
Serious: 9/119 (8%)
Deaths: 0/119

Serious adverse events (5 terms)

ReactionSystemFoot and Ankle Devices
InfectionMusculoskeletal and connective tissue disorders
PainMusculoskeletal and connective tissue disorders
acute aortic dissectionCardiac disorders
Below Knee AmputationMusculoskeletal and connective tissue disorders
Non-UnionMusculoskeletal and connective tissue disorders
Other adverse events (6 terms — click to expand)

ReactionSystemFoot and Ankle Devices
PainMusculoskeletal and connective tissue disorders
Wound Healing ComplicationsMusculoskeletal and connective tissue disorders
AlgodystrophyMusculoskeletal and connective tissue disorders
Blister Dorsal Aspect of Operated FootMusculoskeletal and connective tissue disorders
Inflammatory ScarMusculoskeletal and connective tissue disorders
UlcerMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Infection, Pain, acute aortic dissection, Below Knee Amputation, Non-Union.

Data from ClinicalTrials.gov NCT04118894 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Arthritis

Currently open trials in the same condition.

Other Stryker Trauma and Extremities trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04118894.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing