Clinical trial NCT04607044: Lower Extremity Fixation In Neuropathic Patients Study
Official title: Lower Extremity Fixation In Neuropathic Patients Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neuropathy
Charcot; Disease (Etiology)
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2020-10-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival Analysis of Implants at 1 Year
timeFrame: 1 years
Secondary outcomes:
measure: EQ-5D-5L- Index
timeFrame: 1 year
measure: FAAM-ADL
timeFrame: 1 years
measure: Survival Analysis of Implants at 5 Years
timeFrame: 5 years
measure: Radiographic Assessment
timeFrame: 5 years
measure: EQ-5D-5L-VAS
timeFrame: 1 Year
Other outcomes:
Locations:
city: Trinity
country: United States
facility: Florida Joint Care Institute
state: Florida
city: West Chester
country: United States
facility: Premier Orthopaedic and Sports Medicine
state: Pennsylvania
city: Sparta
country: United States
facility: Central Tennessee Foot and Ankle Center
state: Tennessee
Study officials:
affiliation: Stryker Trauma and Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: