Lower Extremity Fixation In Neuropathic Patients Study (FINS)

Stryker Trauma and Extremities

Status: Terminated

Conditions: Neuropathy; Charcot; Disease (Etiology)

Treatments: Device: SALVATION™ EXTERNAL FIXATION

Study type: Observational

Funder types: Industry

Identifiers

NCT04607044

US20-SAL-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design