Arthritis, Fracture, Fusion of Joint, Rheumatoid Arthritis, Trauma Injury
Conditions
Brief 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
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.
Interventions
DEVICEFoot and Ankle Devices
Wright devices used in foot and ankle procedures
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol (EQ-5D-5L). | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foot and Ankle Ability Measure (FAAM) | 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). |
| Safety Assessment | 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) |
| Surgeon Survey | 1 year | Conducting a surgeon survey including radiographic assessment of fusion and consolidation time |
| Patient Survey | 1 year | Conducting patient surveys to assess current implant status (to include complications) |
Countries
France, Germany, United Kingdom, United States
Participant flow
Recruitment details
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.
Pre-assignment details
No specific method (such as randomization, blinding or stratification) for assigning subjects was used in this protocol. Consecutive subjects at each site meeting all the eligibility criteria were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 119 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lost to Follow-up | 21 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Foot and Ankle Devices | — |
|---|---|---|
| Age, Continuous | 59.49 years STANDARD_DEVIATION 13.34 | — |
| BMI | 28.18 kg/m^2 STANDARD_DEVIATION 5.58 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 79 Participants | — |
| Sex: Female, Male Male | 40 Participants | — |
| Smoking Status Current, > 1 pack/day | 1 Participants | — |
| Smoking Status Current, <= 1 Pack/day | 3 Participants | — |
| Smoking Status Never | 77 Participants | — |
| Smoking Status Previous | 38 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 119 |
| other Total, other adverse events | 19 / 119 |
| serious Total, serious adverse events | 9 / 119 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foot and Ankle Devices | EuroQol (EQ-5D-5L). | 74.1 units on a scale- EQ5D VAS | Standard Deviation 22.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foot and Ankle Devices | Foot and Ankle Ability Measure (FAAM) | 68.6 score on a scale- FAAM SANE | Standard Deviation 25.5 |
Secondary
Patient Survey
Conducting patient surveys to assess current implant status (to include complications)
Time frame: 1 year
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Foot and Ankle Devices | Patient Survey | Experienced any complications associated with your procedure requiring you to seek medical care? | Yes | 7 Participants |
| Foot and Ankle Devices | Patient Survey | Experienced any complications associated with your procedure requiring you to seek medical care? | No | 42 Participants |
| Foot and Ankle Devices | Patient Survey | Any surgery to remove any device parts associated with your foot/ankle procedure? | Yes | 1 Participants |
| Foot and Ankle Devices | Patient Survey | Any surgery to remove any device parts associated with your foot/ankle procedure? | No | 48 Participants |
Secondary
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
Population: Safety is reported in the adverse event section.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foot and Ankle Devices | Safety Assessment | Subjects that Experienced a Serious Adverse Event | 9 Participants |
| Foot and Ankle Devices | Safety Assessment | Subjects that Didn't Experience a Serious Adverse Event | 110 Participants |
Secondary
Surgeon Survey
Conducting a surgeon survey including radiographic assessment of fusion and consolidation time
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foot and Ankle Devices | Surgeon Survey | Wright product performed as intended- Yes | 109 Participants |
| Foot and Ankle Devices | Surgeon Survey | Wright product performed as intended- No | 3 Participants |