Lower Extremity Fixation In Neuropathic Patients Study

Neuropathy Clinical Trial

— FINS  

Official title:

Lower Extremity Fixation In Neuropathic Patients Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04607044
• Other study ID #: US20-SAL-001
• Status: Terminated
• Start date: February 3, 2021
• Est. completion date: October 28, 2022

Study information

• Verified date: June 2023
• Source: Stryker Trauma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Charcot; Disease (Etiology)
• Neuropathy

Intervention

Device:
• SALVATION™ EXTERNAL FIXATION
Wright Medical's lower extremity devices used to treat neuropathic patients

Locations

Country	Name	City	State
United States	Central Tennessee Foot and Ankle Center	Sparta	Tennessee
United States	Florida Joint Care Institute	Trinity	Florida
United States	Premier Orthopaedic and Sports Medicine	West Chester	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Analysis of Implants at 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.	3 years
Secondary	EQ-5D-5L	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).	5 years
Secondary	Foot and Ankle Ability Measure (FAAM)	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.	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 derived from a Kaplan-Meier survival analysis to a performance goal.	5 years
Secondary	Radiographic Assessment	Assess fusion and consolidation time of bony unions utilizing surgeon's evaluations of standard of care x-rays	5 years