A Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery
|ClinicalTrials.gov Identifier: NCT01224119|
Recruitment Status : Unknown
Verified March 2012 by BioSurface Engineering Technologies, Inc.
Recruitment status was: Active, not recruiting
First Posted : October 19, 2010
Last Update Posted : March 9, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Arthritis||Device: Amplex Procedure: Autograft bone||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Multi-Center, Randomized, Pilot Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||April 2012|
|Experimental: Amplex (synthetic bone graft)||
225 micrograms of B2A per cc of ceramic granules
|Active Comparator: Autograft bone||
Procedure: Autograft bone
Bone is collected through a separate incision at the iliac crest or tibia.
- Radiographic fusion [ Time Frame: 6 months ]An independent radiologist will assess radiographic fusion based upon CT imaging.
- Ankle Osteoarthritis Questionnaire [ Time Frame: 6 months ]This is a questionnaire completed by the subject. It consists of a number of questions concerning the amount of pain in the foot and its effect on functional activities.
- Ankle Osteoarthritis Questionnaire [ Time Frame: 12 months ]The is a questionnaire completed by the subject. Its asks a series of questions about pain and function of the treated foot or ankle.
- Radiographic fusion [ Time Frame: 9-12 months ]Radiographic fusion will be assess by a blinded indpenendent radiologists, using CT and X-ray images. The investigator will also assess fusion based on the images and also the overall condition of the subject.
- Various blood tests [ Time Frame: PreOp through 6 months ]Small amounts of blood will be collected at study visits to identify possible changes in blood chemistry, liver function and antibody formation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224119
|Canada, Nova Scotia|
|Dr. Mark Glazebrook|
|Halifax, Nova Scotia, Canada|
|Study Director:||David M Hooper, PhD||BioSurface Engineering Technologies, Inc|
|Principal Investigator:||Mark Glazebrook, MD||Queen Elizabeth II Health Sciences Center Halifax Infirmary|