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Sponsor decision
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Prospective, multi-site, multi-year post-market clinical follow-up study on neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites
The selected design is a US, multi-center, multi-year, non-randomized, prospective observational study. The study subjects included are neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SALVATION™ EXTERNAL FIXATION | Device | Wright Medical's lower extremity devices used to treat neuropathic patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival Analysis of Implants at 1 Year | Compare the pooled cumulative 3-year amputation (above or below the knee) rate of neuropathic patients implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM derived from a Kaplan-Meier survival analysis to a performance goal. | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D-5L- Index | Evaluate improvements in patient-reported pain, function, and social interaction for quality of life from pre-op through each annual visit as assessed by the EQ-5D-5L and its component scores. Health state index scores generally range from less than 0 to 1 with higher scores indicating higher health utility. The health state preferences often represent national or regional values and can therefore differ between countries/regions. |
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Inclusion Criteria:
Exclusion Criteria:
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Neuropathic Patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma and Extremities | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Joint Care Institute | Trinity | Florida | 34655 | United States | ||
| Premier Orthopaedic and Sports Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients | Wright Medicals Lower Extremity devices used to treat Neuropathic Patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients | SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM |
| 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 | Survival Analysis of Implants at 1 Year | Compare the pooled cumulative 3-year amputation (above or below the knee) rate of neuropathic patients implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM derived from a Kaplan-Meier survival analysis to a performance goal. | Given the early termination of the study the device failure analysis is through to 1 year as opposed to 3 years. 42 Subjects received the study device(s). | Posted | Count of Participants | Participants | 1 years |
|
Safety was assessed through the incidence of device related intra-operative and post-operative adverse events/incidents (AEs) from baseline through study termination, up to 1.5 years. The study planned to follow all subjects annually post-operatively for 5 years (however, the study terminated early).
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 | Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients | Wright Medicals Lower Extremity devices used to treat Neuropathic Patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection in foot | Infections and infestations | Systematic Assessment | Infection in foot |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken screw with nonunion at the navicular-cuneiform joint | Product Issues | Systematic Assessment | Broken screw with nonunion at the navicular-cuneiform joint |
As the study was terminated early, outcomes and adverse events can only be reported up to the date of closure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monica Fleeman | Stryker | 251-465-5969 | monica.fleeman@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 27, 2022 | Sep 17, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 14, 2023 | Sep 17, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 year |
| FAAM-ADL | The FAAM has been shown to be valid and responsive in assessing diabetic foot disease and includes 2 subscales: Activities of Daily Living (ADL) Subscale (21 items) and Sports Subscale (8 items). For each subscale patients are asked to answer each question with a single response that most clearly describes their condition within the past week: no difficulty (4 points), slight difficulty (3 points), moderate difficulty (2 points), extreme difficulty (1 point), and unable to do (0 points). To calculate the score for either subscale, the total number of points are added (84 for the ADL subscale and 32 for the sports subscale) and converted to a percentage. A higher score reflects a higher level of physical function. | 1 years |
| Survival Analysis of Implants at 5 Years | Compare the pooled cumulative 5-year amputation (above or below the knee) rate of neuropathic patients implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM derived from a Kaplan-Meier survival analysis to a performance goal. | 5 years |
| Radiographic Assessment | Assess fusion and consolidation time of bony unions utilizing surgeon's evaluations of standard of care x-rays | 5 years |
| EQ-5D-5L-VAS | The second part of the EQ-5D-5L questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). | 1 Year |
| West Chester |
| Pennsylvania |
| 19380 |
| United States |
| Central Tennessee Foot and Ankle Center | Sparta | Tennessee | 38583 | United States |
| Death |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | EQ-5D-5L- Index | Evaluate improvements in patient-reported pain, function, and social interaction for quality of life from pre-op through each annual visit as assessed by the EQ-5D-5L and its component scores. Health state index scores generally range from less than 0 to 1 with higher scores indicating higher health utility. The health state preferences often represent national or regional values and can therefore differ between countries/regions. | Only 31 out of 42 subjects had data available at the 1 year time point for EQ-5D-5L Index. | Posted | Mean | Standard Deviation | score on scale | 1 year |
|
|
|
| Secondary | FAAM-ADL | The FAAM has been shown to be valid and responsive in assessing diabetic foot disease and includes 2 subscales: Activities of Daily Living (ADL) Subscale (21 items) and Sports Subscale (8 items). For each subscale patients are asked to answer each question with a single response that most clearly describes their condition within the past week: no difficulty (4 points), slight difficulty (3 points), moderate difficulty (2 points), extreme difficulty (1 point), and unable to do (0 points). To calculate the score for either subscale, the total number of points are added (84 for the ADL subscale and 32 for the sports subscale) and converted to a percentage. A higher score reflects a higher level of physical function. | The patient did not complete the Sports subscale post-operatively due to physician instructions to avoid those types of activities, so FAAM results reflect the ADL subscore exclusively. A total of 7 out of 42 subjects had available data at the 1 year time point for FAAM-ADL. | Posted | Mean | Standard Deviation | percentage of total score | 1 years |
|
|
|
| Secondary | Survival Analysis of Implants at 5 Years | Compare the pooled cumulative 5-year amputation (above or below the knee) rate of neuropathic patients implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM derived from a Kaplan-Meier survival analysis to a performance goal. | Not Posted | 5 years | Participants |
| Secondary | Radiographic Assessment | Assess fusion and consolidation time of bony unions utilizing surgeon's evaluations of standard of care x-rays | Not Posted | 5 years | Participants |
| Secondary | EQ-5D-5L-VAS | The second part of the EQ-5D-5L questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). | Only 31 out of 42 subjects had data available at the 1 year time point for EQ-5D-5L VAS. | Posted | Mean | Standard Deviation | units on a scale | 1 Year |
|
|
|
| 1 |
| 42 |
| 8 |
| 42 |
| 2 |
| 42 |
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| Loosen External Fixator | Product Issues | Systematic Assessment | Loosen External Fixator |
|
| Broken screw with nonunion at the navicular-cuneiform joint | Product Issues | Systematic Assessment | Broken screw with nonunion at the navicular-cuneiform joint |
|
| Redness and swelling lower leg and ankle | Skin and subcutaneous tissue disorders | Systematic Assessment | Redness and swelling lower leg and ankle |
|
| Infected IM Nail with nonunion of ankle fusion site | Infections and infestations | Systematic Assessment | Infected IM Nail with nonunion of ankle fusion site |
|
| infected wire on external fixator | Infections and infestations | Systematic Assessment | infected wire on external fixator |
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| fractured tibia | Injury, poisoning and procedural complications | Systematic Assessment | fractured tibia |
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| Abcess/cellulitis | Infections and infestations | Systematic Assessment | Abcess/cellulitis |
|
|
| Redness and swelling lower leg and ankle | Skin and subcutaneous tissue disorders | Systematic Assessment | Redness and swelling lower leg and ankle |
|
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