FINS: Lower Extremity Fixation In Neuropathic Patients Study

• Sponsor: Stryker Trauma GmbH (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04607044
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 92.9
• Patients Per Site: 100
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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, and/or VALOR™ NAIL of 200 patients with up to 10 sites

Condition or Disease	Intervention/Treatment	Phase
Neuropathy; Charcot; Disease (Etiology)	Device: SALVATION™ EXTERNAL FIXATION

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, and/or VALOR™ NAIL of 200 patients with up to 10 sites.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Lower Extremity Fixation In Neuropathic Patients Study
• Actual Study Start Date: Feb 3, 2021
• Anticipated Primary Completion Date: Nov 1, 2026
• Anticipated Study Completion Date: Nov 1, 2028

Outcome Measures

Primary Outcome Measures

1. Survival Analysis of Implants at 3 years [3 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 derived from a Kaplan-Meier survival analysis to a performance goal.

Secondary Outcome Measures

1. EQ-5D-5L [5 years]

   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. The second part of the 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).

2. Foot and Ankle Ability Measure (FAAM) [5 years]

   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 the FAAM and its component scores. The ADL and Sports subscales are scored separately. The scores for ADL can range from 0 to 84. The item score total is divided by the highest potential score. This value is then multiplied by 100 to get a percentage. A higher score represents a higher level of physical function. The scores for Sports subscale range from 0 to 32. The item score total is divided by the highest potential score. This value is then multiplied by 100 to get a percentage. A higher score represents a higher level of physical function.

3. 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 derived from a Kaplan-Meier survival analysis to a performance goal.

4. Radiographic Assessment [5 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Willing and able to consent to participate (written, informed consent);

• Willing and able to attend/complete the requested follow-up visits;

• Considered for treatment for Neuropathy with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, and/or VALOR™ NAIL

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Premier Orthopaedic and Sports Medicine	West Chester	Pennsylvania	United States	19380
2	Central Tennessee Foot and Ankle Center	Sparta	Tennessee	United States	38583

Sponsors and Collaborators

• Stryker Trauma GmbH

Investigators

• Study Director: Rebecca Gibson, Stryker Nordic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Trauma GmbH
• ClinicalTrials.gov Identifier: NCT04607044
• Other Study ID Numbers: US20-SAL-001
• First Posted: Oct 28, 2020
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Jan 21, 2022