NeuropathyFINSNCT04607044

Lower Extremity Fixation In Neuropathic Patients Study

An observational study of Neuropathy and Charcot; Disease (Etiology), run by Stryker Trauma and Extremities at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuropathy, Charcot; Disease (Etiology)
What is being tested?: SALVATION™ EXTERNAL FIXATION
Type of treatment: Medical device
How many people: 45 participants
Where: 3 sitesUnited States
Study dates: 3 Feb 2021to 28 Oct 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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

Who may be able to join

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

Show all 10Show fewer

SALVATION™ 2 MIDFOOT NAIL
SALVATION™ 3DI PLATING SYSTEM
T2® ICF SYSTEM
VALOR™ ANKLE FUSIO NAIL SYSTEM

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Central Tennessee Foot and Ankle Center
Sparta, Tennessee, 38583
Florida Joint Care Institute
Trinity, Florida, 34655
Premier Orthopaedic and Sports Medicine
West Chester, Pennsylvania, 19380

Other trials in United States

About this study

Read the 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.

Conditions: Neuropathy, Charcot; Disease (Etiology)
Being tested: SALVATION™ EXTERNAL FIXATION
Medical subject headings: Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SALVATION™ EXTERNAL FIXATIONDevice
Also called SALVATION™ FUSION BOLTS AND BEAMS, SALVATION™ MIDFOOT NAIL, THE SALVATION™ 3DI PLATING SYSTEM, VALOR™ NAIL
Wright Medical's lower extremity devices used to treat neuropathic patients

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 years

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 5 years
Radiographic Assessment
Assess fusion and consolidation time of bony unions utilizing surgeon's evaluations of standard of care x-rays
Measured: 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).
Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 202128 Oct 2022

First posted28 Oct 2020
Study start3 Feb 2021
Primary completion28 Oct 2022
Study completion28 Oct 2022

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NeuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04607044
Sponsor's protocol ID: US20-SAL-001
Acronym: FINS
Status last verified: Jan 2025
First submitted: 13 Oct 2020
Last updated: 9 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lower Extremity Fixation In Neuropathic Patients Study
ClinicalTrials.gov ID: NCT04607044
Acronym / sponsor ID: FINS / US20-SAL-001
Conditions: Neuropathy, Charcot; Disease (Etiology)
Study type: Observational
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 45 participants (actual)
Lead sponsor: Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
Study start: 3 Feb 2021 (actual)
Primary completion: 28 Oct 2022 (actual)
Study completion: 28 Oct 2022 (actual)
First posted: 28 Oct 2020 (actual)
Results: Posted 9 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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

Key inclusion criteria (10 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SALVATION™ EXTERNAL FIXATIONAlso: SALVATION™ FUSION BOLTS AND BEAMS, SALVATION™ MIDFOOT NAIL, THE SALVATION™ 3DI PLATING SYSTEM, VALOR™ NAILWright Medical's lower extremity devices used to treat neuropathic patients	Device	–

Primary outcome

Survival Analysis of Implants at 1 Year
Time frame: 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.

5 secondary outcomes

EQ-5D-5L- Index
Time frame: 1 year
FAAM-ADL
Time frame: 1 years
Survival Analysis of Implants at 5 Years
Time frame: 5 years
Radiographic Assessment
Time frame: 5 years
EQ-5D-5L-VAS
Time frame: 1 Year

Results and safety

Results posted to the registry on 9 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients	45	0

Primary outcome: Survival Analysis of Implants at 1 Year

Time frame: 1 years. Count of participants. Unit: Participants

Measure	Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients n = 42
Value	1

Population analysed: 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).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wright Medicals Lower Extremity Devices Used to Treat Neuropathic Patients	8 of 42 (19%)	2 of 42 (4.8%)	1 of 42

Limitations and caveats (from the sponsor): As the study was terminated early, outcomes and adverse events can only be reported up to the date of closure.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rebecca Gibson study director

Stryker Trauma and Extremities

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Neuropathy and Charcot; Disease (Etiology), run by Stryker Trauma and Extremities at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival Analysis of Implants at 1 Year (time frame: 1 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.