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NCT03028415 · ClinicalTrials.gov registry record · NA
AMPLEX Ankle Fusion and Hindfoot
A NA study, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
NCT03028415: Completed NA study, sponsored by Ferring Pharmaceuticals.
NCT03028415 is a NA study that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03028415, a NA study, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
Study Summary
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.
Primary Outcome
Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale \[VAS\]); 2. Absence of significant graft harvest site pain (\<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse even
Interventions
- DEVICE AMPLEX
- PROCEDURE Autogenous Bone Graft (ABG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2017-07-28 |
| Est. Completion | 2020-07-09 |
| Phase | NA |
What the finished NCT03028415 record still lists
NCT03028415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which AMPLEX is the first listed.
NCT03028415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03028415 about?
NCT03028415 is a clinical study titled "AMPLEX Ankle Fusion and Hindfoot". To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.
What is the current status of trial NCT03028415?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2017-07-28. Estimated completion is 2020-07-09.
What interventions are being tested in trial NCT03028415?
The interventions under investigation include: AMPLEX (DEVICE), Autogenous Bone Graft (ABG) (PROCEDURE).
Who is sponsoring clinical trial NCT03028415?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03028415's enrollment target sits among peer trials
56 1262nd of 2000 higher than 737 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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