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
Group
Value
95% CI
Foot and Ankle Devices
74.1
± 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).
Group
Value
95% CI
Foot and Ankle Devices
68.6
± 25.5
Safety AssessmentSecondary· 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)
Group
Value
95% CI
Foot and Ankle Devices
9
Foot and Ankle Devices
110
Surgeon SurveySecondary· 1 year
Conducting a surgeon survey including radiographic assessment of fusion and consolidation time
Group
Value
95% CI
Foot and Ankle Devices
109
Foot and Ankle Devices
3
Patient SurveySecondary· 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?
Group
Value
95% CI
Foot and Ankle Devices
7
Foot and Ankle Devices
42
Any surgery to remove any device parts associated with your foot/ankle procedure?
Group
Value
95% CI
Foot and Ankle Devices
1
Foot and Ankle Devices
48
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.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stryker Trauma and Extremities
Last refreshed: 14 January 2025
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.