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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
Alberta Health Services
Calgary, Alberta, Canada
Horizon Health Network
Moncton, New Brunswick, Canada
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada
Halifax Infirmary
Halifax, Nova Scotia, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Resorption of Study Device
Number of participants with any study device remaining visible on CT
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: Baseline
Range of Motion
Range of knee motion (active flexion) in degrees
Time frame: 6 weeks
Subsidence of Joint Surface
Amount of collapse of the joint surface, measured in mm, on plain x-ray. Reported as number of participants with at least 2mm of subsidence on x-ray.
Time frame: 6 weeks, 3 months, 6 months, 12 months
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 6 weeks
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 3 months
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 12 months
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: Baseline
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 6 weeks
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 3 months
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 12 months
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: Baseline
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 6 weeks
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 3 months
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 12 months
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: Baseline
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 6 weeks
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 3 months
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 12 months
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: Baseline
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 6 weeks
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 3 months
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time frame: 12 months
Range of Motion
Range of knee motion (active flexion) in degrees
Time frame: 3 months
Range of Motion
Range of knee motion (active flexion) in degrees
Time frame: 6 months
Range of Motion
Range of knee motion (active flexion) in degrees
Time frame: 12 months
Resorption of Study Device
Number of participants with any study device remaining visible on x-ray
Time frame: 3 months
Resorption of Study Device
Number of participants with any study device remaining visible on x-ray
Time frame: 6 months
Resorption of Study Device
Number of participants with any study device remaining visible on x-ray
Time frame: 12 months
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