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Antibiotic-Impregnated Biodegradable Material
Calcium Sulfate + Antibiotics + Internal Fixation for Tibial Fracture
N/A
Waitlist Available
Led By Ross Leighton, MD
Research Sponsored by Ross Leighton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3 months, 6 months, 12 months
Awards & highlights
No Placebo-Only Group
Summary
This is a prospective clinical trial of tibial plateau fractures treated with internal fixation and a calcium sulfate graft which can be mixed with antibiotics and molded into various bead sizes for implantation into bone defects. The graft material chosen for this study is STIMULAN Rapid Cure (Biocomposites, UK), which is approved for use as a bone void filler and may be mixed with a variety of antibiotics. The combination of STIMULAN + antibiotic in bead form is the "study device". Our primary study aim is to look at resorption and remodeling of the study device into bone. Another important aim of the study is to look at subsidence, or collapse, of the joint surface.
Eligible Conditions
- Tibial Fracture
- Internal Fracture Fixation
- Intra-Articular Fractures
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks, 3 months, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 3 months, 6 months, 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Calcium Sulfate + Antibiotics + Internal FixationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcium Sulfate + Antibiotics + Internal Fixation
2015
N/A
~30
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Who is running the clinical trial?
Ross LeightonLead Sponsor
4 Previous Clinical Trials
436 Total Patients Enrolled
Biocomposites LtdIndustry Sponsor
4 Previous Clinical Trials
240 Total Patients Enrolled
Ross Leighton, MDPrincipal InvestigatorNova Scotia Health Authority
1 Previous Clinical Trials
100 Total Patients Enrolled
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