CERAMENT™|G - Bone Healing and Re-infection Prophylaxis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Advances in bone in-growth after insertion of the device (during follow up).
研究概览
简要总结
The surgical management of long bone infections is often challenging. Adequate surgical debridement decreases the bacterial load, removes dead tissues, and gives a chance for the host immune system and antibiotics to arrest infection. Adequate debridement may leave a large bony defect. An appropriate management of the dead space is essential to arrest the disease, and for maintenance of the bone's integrity. The current strategy includes the use of antibiotic-loaded bone cement that can be used to sterilize and temporarily maintain the dead space. The cement are usually removed after 2 to 4 weeks and replaced with a cancellous graft harvested from the hip of the patient.
CERAMENT™| G is a CE-marked resorbable ceramic bone graft substitute composed by calcium sulfate and calcium hydroxyapatite, intended to fill gaps and voids in the skeleton system and to promote bone healing. The antibiotic gentamicin is included in the ceramic to prevent colonization of gentamicin-sensible microorganisms in order to protect bone healing.
The aim of this study is to investigate the device absorption and bone in-growth of CERAMENT™| G in a surgically revised bone infection. In addition, bone healing and infection non-recurrence will be evaluated during 12 months of follow-up. The investigators expect a treatment success of >90 % and that a similar bone healing will be obtained as with a standard two-stage surgical procedure. In addition, the investigators believe that the use of CERAMENT™| G will be of advantage for the patient as bone healing will be achieved with a one-stage surgical procedure (in combination with antibiotic therapy), instead of a two-stage procedure, thus decreasing potential surgery-related complications.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a long bone infection in femur, tibia, humerus or radius
- •Candidate for one stage procedure
- •Patients above the age of 18
- •Written informed consent obtained before any study-related activities
- •Patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program
排除标准
- •Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
- •Hypersensitivity to aminoglycoside antibiotics
- •Myasthenia gravis
- •Severe renal impairment
- •Pre existing calcium metabolism disorder.
- •Women who are pregnant or breastfeeding (a pregnancy test will be done in women of childbearing potential)
- •History of hypersensitivity to the investigational device or any of its ingredients
结局指标
主要结局
Advances in bone in-growth after insertion of the device (during follow up).
时间窗: 3 and 12 months after surgery.
Bone in-growth will be evaluated by localized CT-scans 3 and 12 months after surgery.
Degree of device absorption after insertion of the device (during follow-up).
时间窗: 3 and 12 months after surgery.
The degree of device absorption will be evaluated by localized CT-scans 3 and 12 months after surgery.
次要结局
- Bone healing(6 weeks, 3 months, 6 months and 12 months after surgery.)
- Infection non-recurrence(During hospitalisation and 6 weeks, 3 months, 6 months and 12 months after surgery.)
- Serum gentamicin levels(24 h, 48 h and 72 h after surgery.)
研究者
Dr. Olivier Borens
Head of Service of Traumatology and Septic Surgical Unit
University of Lausanne Hospitals