A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Composite Endpoint
研究概览
简要总结
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.
详细描述
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.
The purpose of this post market prospective cohort study is to obtain longer-term clinical and radiographic data on the safety and effectiveness of CERAMENT G as part of the surgical treatment of Osteomyelitis in a single-stage procedure.
Detailed questions to be answered are:
- What is the nature, severity, and frequency of incomplete new bone formation?
- What is the nature, severity, and frequency of the risks of probable adverse events and serious adverse events associated with incomplete new bone formation, including pathologic fractures and reinfection?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects meeting the following inclusion criteria are to be included in the analysis:
- •Patients receiving CERAMENT G subsequent to surgical excision of osteomyelitis, with Cierny-Mader classification grades III or IV, who require dead-space management of a bone defect following surgical debridement and excision of infection.
- •Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:
- •the presence of a sinus
- •the presence of an abscess or intra-operative pus
- •the presence of positive supportive histology
- •two or more microbiological cultures with indistinguishable organisms (defined as cultures resulting in identification of the same microbe (e.g., Staph aureus) with similar antimicrobial sensitivity) Notes: In cases where cultures are negative, a patient will be included in the study only if there is positive supportive histology combined with the presence of a draining sinus or intra-operative pus. Infected non-unions will be included only if the bone loss is < 1cm after debridement and excision of bone has been performed.
排除标准
- •The subject will be excluded from the study if:
- •Skeletal immaturity, defined as pre-operative/ screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study)
- •Those unable to give informed consent for inclusion in the trial, or those not willing to be included
- •A known allergy or reaction to gentamicin or calcium sulfate
- •Treatment with a combination of different antibiotic-eluting bone graft substitutes
- •They have a segmental bone defect > 1cm
- •Infection of the spine
研究组 & 干预措施
CERAMENT G
Subjects receiving CERAMENT G as part of the surgical treatment of Osteomyelitis
干预措施: CERAMENT G (Device)
结局指标
主要结局
Composite Endpoint
时间窗: 36 months
Overall subject success requires all four of the following at 36 months post-op: * absence of a reinfection of the original site of osteomyelitis; * absence of purulent drainage and wound dehiscence/breakdown * absence of a secondary surgical intervention, e.g., grafting or removal of residual CERAMENT G at the original site; and, * a lack of serious adverse events associated with incomplete new bone formation, including pathologic fracture of the treated limb
Co-Primary Endpoint
时间窗: 36 months
A trend showing increasing new bone formation and decreasing CERAMENT G as determined by a comparison of baseline and interim post-operative timepoint radiographic evaluations out to 36 months post-operative
次要结局
- Clinical Success(36 months)
- Radiographic Succcess(36 months)