Trials / Completed
CompletedNCT03028415
AMPLEX Ankle Fusion and Hindfoot
A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AMPLEX | A bone graft substitute |
| PROCEDURE | Autogenous Bone Graft (ABG) | Control material administered by surgical implant |
Timeline
- Start date
- 2017-07-28
- Primary completion
- 2020-01-09
- Completion
- 2020-07-09
- First posted
- 2017-01-23
- Last updated
- 2021-03-11
- Results posted
- 2021-03-11
Locations
36 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03028415. Inclusion in this directory is not an endorsement.