Lower Extremity Fixation In Neuropathic Patients Study
Stopped early
Conditions studied: Neuropathy, Charcot; Disease (Etiology)
In brief
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
Key facts
- Study ID
- NCT04607044
- Run by
- Stryker Trauma and Extremities
- People needed
- 45
- Starts
- 2021-02-03
- Expected to finish
- 2022-10-28
- Last updated by the study team
- 2025-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Florida Joint Care Institute — Trinity, Florida, United States
- Premier Orthopaedic and Sports Medicine — West Chester, Pennsylvania, United States
- Central Tennessee Foot and Ankle Center — Sparta, Tennessee, United States
Full record on ClinicalTrials.gov
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