Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tibial Fractures
- Sponsor
- Ross Leighton
- Enrollment
- 30
- Locations
- 5
- Primary Endpoint
- Resorption of Study Device
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Ross Leighton
Orthopaedic Surgeon
Nova Scotia Health Authority
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Resorption of Study Device
Time Frame: 6 months
Number of participants with any study device remaining visible on CT
Secondary Outcomes
- Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale(12 months)
- Resorption of Study Device(12 months)
- Knee Injury Osteoarthritis Outcome Score - Pain Subscale(12 months)
- Range of Motion(12 months)
- Subsidence of Joint Surface(6 weeks, 3 months, 6 months, 12 months)
- Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale(12 months)
- Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale(12 months)
- Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale(12 months)