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Due to COVID the enrollment into the study was delayed. Sponsor chose to collect clinical data via alternative methods.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot and Ankle Devices | Device | Wright devices used in foot and ankle procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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The Instructions for Use (IFU) for each individual product can be found at http://www.wright.com/prescribing-use-3.
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma and Extremities | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercer-Bucks Orthopaedics | Hamilton | New Jersey | 08691 | United States | ||
| OrthoCarolina |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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'. | Posted | Mean | Standard Deviation | units on a scale- EQ5D VAS | 1 year |
|
Surgery to 1 year
Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute aortic dissection | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Seidman, Manager, Clinical Research | Stryker | 9016338616 | jennifer.seidman@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2019 | Aug 12, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2021 | Aug 12, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D001172 | Arthritis, Rheumatoid |
| D050723 | Fractures, Bone |
| D000081084 | Accidental Injuries |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| 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) | 1 year |
| Surgeon Survey | Conducting a surgeon survey including radiographic assessment of fusion and consolidation time | 1 year |
| Patient Survey | Conducting patient surveys to assess current implant status (to include complications) | 1 year |
| Charlotte |
| North Carolina |
| 28207 |
| United States |
| CHRU Tours, Hôpital Trousseau | Tours | 37044 | France |
| Hessingpark Clinic | Augsburg | Germany |
| Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust | Oswestry | Shropshire | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Smoking Status | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study. |
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale- FAAM SANE | 1 year |
|
|
|
| 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) | Safety is reported in the adverse event section. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Surgeon Survey | Conducting a surgeon survey including radiographic assessment of fusion and consolidation time | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Patient Survey | Conducting patient surveys to assess current implant status (to include complications) | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 119 |
| 9 |
| 119 |
| 19 |
| 119 |
| Below Knee Amputation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Infection | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-Union | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Algodystrophy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Blister Dorsal Aspect of Operated Foot | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Inflammatory Scar | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Wound Healing Complications | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Ulcer | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014947 | Wounds and Injuries |
| No |
|