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Synthetic Bone Graft Material

Amplex (synthetic bone graft) for Arthritis

Phase 1 & 2
Waitlist Available
Led By Mark Glazebrook, MD
Research Sponsored by BioSurface Engineering Technologies, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9-12 months
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9-12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Ankle Osteoarthritis Questionnaire
Radiographic fusion
Various blood tests

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Amplex (synthetic bone graft)Experimental Treatment1 Intervention
Group II: Autograft boneActive Control1 Intervention

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Who is running the clinical trial?

BioSurface Engineering Technologies, IncLead Sponsor
2 Previous Clinical Trials
46 Total Patients Enrolled
Mark Glazebrook, MDPrincipal InvestigatorQueen Elizabeth II Health Sciences Center Halifax Infirmary
1 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Arthritis
250 Patients Enrolled for Arthritis
David M Hooper, PhDStudy DirectorBioSurface Engineering Technologies, Inc
1 Previous Clinical Trials
22 Total Patients Enrolled
~2 spots leftby Sep 2025
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