Lower Extremity Fixation In Neuropathic Patients Study

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-03

Study Completion Date

2022-10-28

Brief Summary

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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

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Detailed Description

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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

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Neuropathy Charcot; Disease (Etiology)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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SALVATION™ EXTERNAL FIXATION

Wright Medical's lower extremity devices used to treat neuropathic patients

Intervention Type DEVICE

Other Intervention Names

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SALVATION™ FUSION BOLTS AND BEAMS SALVATION™ MIDFOOT NAIL THE SALVATION™ 3DI PLATING SYSTEM VALOR™ NAIL HOFFMANN® LRF SYSTEM T2® ICF SYSTEM

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No