Trials / Unknown
UnknownNCT01224119
A Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery
A Multi-Center, Randomized, Pilot Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- BioSurface Engineering Technologies, Inc · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The current research study evaluates an investigational medical device called Amplex B2A(TM) Peptide Enhanced Ceramic Granules ("Amplex") for use in foot and ankle fusion. Amplex is a synthetic bone graft material. The most frequently used graft material is bone collected from the patient (autograft). Autograft involves a secondary incision with the risks of infection and lasting pain. The purpose of this study is to determine if Amplex is a safe and effective alternative to autograft.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Amplex | 225 micrograms of B2A per cc of ceramic granules |
| PROCEDURE | Autograft bone | Bone is collected through a separate incision at the iliac crest or tibia. |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2012-04-01
- Completion
- 2012-04-01
- First posted
- 2010-10-19
- Last updated
- 2012-03-09
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT01224119. Inclusion in this directory is not an endorsement.