Trial Outcomes & Findings for Lower Extremity Fixation In Neuropathic Patients Study (NCT NCT04607044)

NCT ID: NCT04607044

Last Updated: 2025-01-09

Results Overview

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.

• Recruitment status: TERMINATED
• Target enrollment: 45 participants
• Primary outcome timeframe: 1 years
• Results posted on: 2025-01-09

Participant Flow

Participant milestones

Measure	Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients Wright Medicals Lower Extremity devices used to treat Neuropathic Patients
Overall Study STARTED	45
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	45

Reasons for withdrawal

Measure	Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients Wright Medicals Lower Extremity devices used to treat Neuropathic Patients
Overall Study Study Early Termination by Sponsor.	40
Overall Study Adverse Event	1
Overall Study Did not receive study device	3
Overall Study Death	1

Baseline Characteristics

Lower Extremity Fixation In Neuropathic Patients Study

Baseline characteristics by cohort

Measure	Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients n=42 Participants 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
Age, Continuous	57.09 years STANDARD_DEVIATION 12.21 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients n=42 Participants Wright Medicals Lower Extremity devices used to treat Neuropathic Patients
Survival Analysis of Implants at 1 Year	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Only 31 out of 42 subjects had data available at the 1 year time point for 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.

Outcome measures

Measure	Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients n=31 Participants Wright Medicals Lower Extremity devices used to treat Neuropathic Patients
EQ-5D-5L- Index	0.88 score on scale Standard Deviation 0.11

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients n=7 Participants Wright Medicals Lower Extremity devices used to treat Neuropathic Patients
FAAM-ADL	96.9 percentage of total score Standard Deviation 2.85

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Assess fusion and consolidation time of bony unions utilizing surgeon's evaluations of standard of care x-rays

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Year

Population: Only 31 out of 42 subjects had data available at the 1 year time point for 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).

Outcome measures

Measure	Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients n=31 Participants Wright Medicals Lower Extremity devices used to treat Neuropathic Patients
EQ-5D-5L-VAS	86.3 units on a scale Standard Deviation 8.80

Adverse Events

Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients

Serious events: 8 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients n=42 participants at risk Wright Medicals Lower Extremity devices used to treat Neuropathic Patients
Infections and infestations Infection in foot	2.4% 1/42 • Number of events 1 • 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.
Product Issues Loosen External Fixator	2.4% 1/42 • Number of events 1 • 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.
Product Issues Broken screw with nonunion at the navicular-cuneiform joint	2.4% 1/42 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Redness and swelling lower leg and ankle	2.4% 1/42 • Number of events 1 • 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.
Infections and infestations Infected IM Nail with nonunion of ankle fusion site	2.4% 1/42 • Number of events 1 • 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.
Infections and infestations infected wire on external fixator	2.4% 1/42 • Number of events 1 • 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.
Injury, poisoning and procedural complications fractured tibia	2.4% 1/42 • Number of events 1 • 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.
Infections and infestations Abcess/cellulitis	2.4% 1/42 • Number of events 1 • 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.

Other adverse events

Measure	Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients n=42 participants at risk Wright Medicals Lower Extremity devices used to treat Neuropathic Patients
Product Issues Broken screw with nonunion at the navicular-cuneiform joint	2.4% 1/42 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Redness and swelling lower leg and ankle	2.4% 1/42 • Number of events 1 • 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.

Additional Information

Monica Fleeman

Stryker

Phone: 251-465-5969

Email: monica.fleeman@stryker.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place