NCT04607044

Lower Extremity Fixation In Neuropathic Patients Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuropathy
• Charcot; Disease (Etiology)

Interventions

Type	Name	Description
DEVICE	SALVATION™ EXTERNAL FIXATION	Wright Medical's lower extremity devices used to treat neuropathic patients

Timeline

• Start date: 2021-02-03
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2020-10-28
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study