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A Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery

NCT01224119 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-03-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • BioSurface Engineering Technologies, Inc

    lead INDUSTRY

Principal Investigators

  • David M Hooper, PhD · BioSurface Engineering Technologies, Inc

  • Mark Glazebrook, MD · Queen Elizabeth II Health Sciences Center Halifax Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01224119 on ClinicalTrials.gov