Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Resorption of Study Device
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Resorption of Study Device
时间窗: 6 months
Number of participants with any study device remaining visible on CT
次要结局
- 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)
研究者
Ross Leighton
Orthopaedic Surgeon
Nova Scotia Health Authority