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NCT04607044 · ClinicalTrials.gov registry record
Lower Extremity Fixation In Neuropathic Patients Study
A clinical trial, sponsored by Stryker Trauma and Extremities.
- Terminated
- Registry status
- 45
- Enrollment target
NCT04607044: Clinical Trial study, sponsored by Stryker Trauma and Extremities.
NCT04607044 is a clinical trial that was terminated before completion, run by Stryker Trauma and Extremities. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04607044 was terminated before completion, sponsored by Stryker Trauma and Extremities.
- TERMINATED
- Registry status
- 45 participants
- Enrollment target
Study 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
Primary Outcome
Compare the pooled cumulative 3-year amputation (above or below the knee) rate of neuropathic patients 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 derived from a Kaplan-Meier survival analysis to a performance goal.
Interventions
- DEVICE SALVATION™ EXTERNAL FIXATION
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-02-03 |
| Est. Completion | 2022-10-28 |
Why NCT04607044 stopped before completion
NCT04607044 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which SALVATION™ EXTERNAL FIXATION is the first listed.
NCT04607044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04607044 about?
NCT04607044 is a clinical study titled "Lower Extremity Fixation In Neuropathic Patients Study". 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...
What is the current status of trial NCT04607044?
This trial is currently terminated. The enrollment target is 45 participants. The study started on 2021-02-03. Estimated completion is 2022-10-28.
What interventions are being tested in trial NCT04607044?
The interventions under investigation include: SALVATION™ EXTERNAL FIXATION (DEVICE).
Who is sponsoring clinical trial NCT04607044?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
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