An observational study in Arthritis, Rheumatoid Arthritis and Fracture, sponsored by Stryker Trauma and Extremities. Terminated at 5 sites in 4 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Stryker Trauma and Extremities · Observational
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
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 119 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Stryker Trauma and Extremities is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The Instructions for Use (IFU) for each individual product can be found at http://www.wright.com/prescribing-use-3.
Exclusion Criteria:
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
Wright devices used in foot and ankle procedures
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'.
Time frame: 1 year
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).
Time frame: 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)
Time frame: 1 year
Surgeon Survey
Conducting a surgeon survey including radiographic assessment of fusion and consolidation time
Time frame: 1 year
Patient Survey
Conducting patient surveys to assess current implant status (to include complications)
Time frame: 1 year
Overall, 119 subjects were enrolled and treated with a study device at 5 sites in the private clinic and hospital setting in the France, Germany, United States and United Kingdom. A subject may have received more than one of the devices under investigation. The first subject was enrolled on January 22, 2020 (aligned with protocol) and the last subject was enrolled on November 1, 2021.
| Milestone | Foot and Ankle Devices |
|---|---|
| Started | 119 |
| Completed | 84 |
| Not completed | 35 |
| Withdrew: Lost to follow-up | 21 |
| Withdrew: Withdrawal by subject | 10 |
| Withdrew: Adverse event | 4 |
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'.
| units on a scale- EQ5D VAS | Foot and Ankle Devices |
|---|---|
| EuroQol (EQ-5D-5L). | 74.1 ± 22.5 |
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).
| score on a scale- FAAM SANE | Foot and Ankle Devices |
|---|---|
| Foot and Ankle Ability Measure (FAAM) | 68.6 ± 25.5 |
Identifying and reporting the safety of the implant in terms of complications and adverse events. (This is reported in the Adverse Event Section)
| Participants | Foot and Ankle Devices |
|---|---|
| Subjects that Experienced a Serious Adverse Event | 9 |
| Subjects that Didn't Experience a Serious Adverse Event | 110 |
Conducting a surgeon survey including radiographic assessment of fusion and consolidation time
| Participants | Foot and Ankle Devices |
|---|---|
| Wright product performed as intended- Yes | 109 |
| Wright product performed as intended- No | 3 |
Conducting patient surveys to assess current implant status (to include complications)
| Participants | Foot and Ankle Devices |
|---|---|
| Experienced any complications associated with your procedure requiring you to seek medical care? — Yes | 7 |
| Experienced any complications associated with your procedure requiring you to seek medical care? — No | 42 |
| Any surgery to remove any device parts associated with your foot/ankle procedure? — Yes | 1 |
| Any surgery to remove any device parts associated with your foot/ankle procedure? — No | 48 |
Collected over Surgery to 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Foot and Ankle Devices | 0/119 (0%) | 9/119 (7.6%) | 19/119 (16%) |
| Event | Foot and Ankle Devices |
|---|---|
| InfectionMusculoskeletal and connective tissue disorders | 4/119 |
| PainMusculoskeletal and connective tissue disorders | 2/119 |
| acute aortic dissectionCardiac disorders | 1/119 |
| Below Knee AmputationMusculoskeletal and connective tissue disorders | 1/119 |
| Non-UnionMusculoskeletal and connective tissue disorders | 1/119 |
| Event | Foot and Ankle Devices |
|---|---|
| PainMusculoskeletal and connective tissue disorders | 12/119 |
| Wound Healing ComplicationsMusculoskeletal and connective tissue disorders | 5/119 |
| AlgodystrophyMusculoskeletal and connective tissue disorders | 1/119 |
| Blister Dorsal Aspect of Operated FootMusculoskeletal and connective tissue disorders | 1/119 |
| Inflammatory ScarMusculoskeletal and connective tissue disorders | 1/119 |
| UlcerMusculoskeletal and connective tissue disorders | 1/119 |
| Age, Continuous(years) | Foot and Ankle Devices |
|---|---|
| Mean | 59.49 ± 13.34 |
| Sex: Female, Male(Participants) | Foot and Ankle Devices |
|---|---|
| Female | 79 |
| Male | 40 |
| Race and Ethnicity Not Collected(Participants) | Foot and Ankle Devices |
|---|
| Smoking Status(Participants) | Foot and Ankle Devices |
|---|---|
| Never | 77 |
| Previous | 38 |
| Current, <= 1 Pack/day | 3 |
| Current, > 1 pack/day | 1 |
| BMI(kg/m^2) | Foot and Ankle Devices |
|---|---|
| Mean | 28.18 ± 5.58 |
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Stryker Trauma and Extremities