Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial

Study Overview
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Brief Summary
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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.

Conditions
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Tibial Fractures, Intra-Articular Fractures, Fracture Fixation, Internal

Intervention / Treatment
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* Device: Calcium Sulfate + Antibiotics + Internal Fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (skeletally mature) men or women; Acute, closed, tibial plateau fractures, Schatzker grade 1 through 5; Internal fixation and use of study device per protocol; Fracture repair within 30 days of injury; Signed informed consent to participate in study. Exclusion Criteria: Uncontrolled diabetes; Severe degenerative or metabolic bone disease; Malignancy; Severe vascular or neurologic disease; Alcoholism; Substance abuse; Use of systemic steroids; Immunosuppressive therapy; Hypercalcaemia; Renal-compromised patients; Osteomyelitis or chronic infection in the study limb; Women who are pregnant or breast-feeding.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium Sulfate + Antibiotics + Internal Fixation<br> | Device: Calcium Sulfate + Antibiotics + Internal Fixation<br>* 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.<br>* Other names: STIMULAN Rapid Cure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resorption of Study Device | Number of participants with any study device remaining visible on CT | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| Range of Motion | Range of knee motion (active flexion) in degrees | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 months | 
| Range of Motion | Range of knee motion (active flexion) in degrees | 3 months | 
| Range of Motion | Range of knee motion (active flexion) in degrees | 6 months | 
| Range of Motion | Range of knee motion (active flexion) in degrees | 12 months | 
| Resorption of Study Device | Number of participants with any study device remaining visible on x-ray | 3 months | 
| Resorption of Study Device | Number of participants with any study device remaining visible on x-ray | 6 months | 
| Resorption of Study Device | Number of participants with any study device remaining visible on x-ray | 12 months |