Clinical Results of Chronic Cavitary Long-bone Osteomyelitis Treatment Using S53P4 Bioactive Glass; a Multi-center Study
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 主要终点
- Absence of signs of chronic osteomyelitis on radiographic imaging (2/2)
研究概览
简要总结
This clinical trial studies the clinical effectiveness of S53P4 bioactive glass (BAG) as a bacterial growth inhibiting bone graft substitute in a one-stage or two-stage surgical procedure for treatment of chronic long bone osteomyelitis.
详细描述
In this prospective multicenter study, patients from two different university hospitals in the Netherlands were included. Treatment consisted of debridement surgery, implantation of S53P4-BAG, if necessary wound closure by a plastic surgeon and additional culture based systemic antibiotics. Primary outcome was eradication of infection based on clinical presentation, radiographic imaging and laboratory tests. Secondary analysis was performed on probable risk factors for treatment failure after S53P4-BAG implantation.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical, radiographic and/or laboratory study confirmed chronic osteomyelitis of long bones
- •Patients who are physically and mentally willing and able to comply with postoperative functional evaluation.
- •Patients that can read and understand the Dutch language.
排除标准
- •Patients with an diabetic ulcer related chronic osteomyelitis
- •Patients that are pregnant.
- •Patients who are unwilling to cooperate with the study protocol and follow-up schedule.
- •Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- •Patients with malignancy - active malignancy within last 1 year
- •Patients known with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (severe osteoporosis requiring medication, Paget's disease, renal osteodystrophy,hypercalcemia ) or is immunologically suppressed, or receiving steroids in excess of physiologic dose.
- •Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
- •Patients with systemic or metabolic disorders leading to progressive bone deterioration
- •Patients with other concurrent illnesses that are likely to affect their outcome such as all autoimmune diseases (including RA), sickle cell anaemia, systemic lupus erythematosus, psoriasis, not controlled type 1/2 diabetes or renal disease requiring dialysis.
- •Patients with a known sensitivity to device materials
- •Patients that are an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
结局指标
主要结局
Absence of signs of chronic osteomyelitis on radiographic imaging (2/2)
时间窗: 1 - 5 years follow-up
Radiographic analysis of X-ray or CT images of the affected bone Based on a combination of 2 different infection paramaters Parameter 2: - Periostal reactions
Eradication of infection In clinical presentation
时间窗: 1-5 years follow-up
Based on the following Clinical Signs: - Absence of a draining fistula, redness, swelling, pain and fever (\>38,5 degrees of celcius)
Eradication of infection in blood sample analysis (1/3)
时间窗: 1 - 5 years follow-up
Based on a combination of 3 different infection parameters; parameter 1 is C-Reactive protein (\<10mg/L), collected from a venapuncture.
Absence of signs of chronic osteomyelitis on radiographic imaging (1/2)
时间窗: 1 - 5 years follow-up
Radiographic analysis of X-ray or CT images of the affected bone Based on a combination of 2 different infection paramaters Parameter 1: - Bone destruction
Eradication of infection in blood sample analysis (3/3)
时间窗: 1 - 5 years follow-up
Based on a combination of 3 different infection parameters; parameter 3 is Erythrocyte Sedimantation Rate (\<22mm/hour) collected from a venapuncture.
Eradication of infection in blood sample analysis (2/3)
时间窗: 1 - 5 years follow-up
Based on a combination of 3 different infection parameters; parameter 2 is Leukocyte count (\<11 x 10E9 cells/L); collected from a venapuncture.
次要结局
- Complication registration(1-5 years follow-up)
研究者
Tom van Vugt
Principal Investigator, Orthopedic Resident
Academisch Ziekenhuis Maastricht