Charcot; Disease (Etiology), Neuropathy
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICESALVATION™ EXTERNAL FIXATION
Wright Medical's lower extremity devices used to treat neuropathic patients
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
No
Inclusion criteria
* Subject is a male or non-pregnant female age 18 years or older at the time of surgery; * Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan (CIP); and * Subject has neuropathy and is intended to be treated for deformity with the one or a combination of the below Systems in accordance with the legally cleared/ approved IFU and Surgical Technique Manual. * HOFFMANN® LRF SYSTEM * SALVATION™ EXTERNAL FIXATION SYSTEM * SALVATION™ FUSION BOLTS AND BEAMS * SALVATION™ 2 MIDFOOT NAIL * SALVATION™ 3DI PLATING SYSTEM * T2® ICF SYSTEM * VALOR™ ANKLE FUSIO NAIL SYSTEM
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 |
|---|---|---|
| Survival Analysis of Implants at 1 Year | 1 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L- Index | 1 year | 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. |
| FAAM-ADL | 1 years | 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. |
| Survival Analysis of Implants at 5 Years | 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. |
| Radiographic Assessment | 5 years | Assess fusion and consolidation time of bony unions utilizing surgeon's evaluations of standard of care x-rays |
| EQ-5D-5L-VAS | 1 Year | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Did not receive study device | 3 |
| Overall Study | Study Early Termination by Sponsor. | 40 |
Baseline characteristics
| Characteristic | Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients |
|---|---|
| Age, Continuous | 57.09 years STANDARD_DEVIATION 12.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 42 |
| other Total, other adverse events | 2 / 42 |
| serious Total, serious adverse events | 8 / 42 |
Outcome results
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.
Time frame: 1 years
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients | Survival Analysis of Implants at 1 Year | 1 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.
Time frame: 1 year
Population: Only 31 out of 42 subjects had data available at the 1 year time point for EQ-5D-5L Index.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients | EQ-5D-5L- Index | 0.88 score on scale | Standard Deviation 0.11 |
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).
Time frame: 1 Year
Population: Only 31 out of 42 subjects had data available at the 1 year time point for EQ-5D-5L VAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients | EQ-5D-5L-VAS | 86.3 units on a scale | Standard Deviation 8.8 |
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.
Time frame: 1 years
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients | FAAM-ADL | 96.9 percentage of total score | Standard Deviation 2.85 |
Secondary
Radiographic Assessment
Assess fusion and consolidation time of bony unions utilizing surgeon's evaluations of standard of care x-rays
Time frame: 5 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.
Time frame: 5 years