CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- incidence of post-surgical infection
研究概览
简要总结
Open-label, multicentre, prospective cohort, observational clinical trial with a retrospective control group to evaluate the effectiveness and safety of CERAMENTTM| G or V used for filling of bone defects in the tibia and / or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for PJI or aseptic loosening.
The results will be compared to a cohort of patients, which have been treated before the introduction of CERAMENTTM|G or V for the same indication.
Due to the observational character of the study, there will be no patient randomization and the clinicians in the study will remain entirely free to decide on the treatment of the patients according to established clinical practice.
Only patients for whom therapeutic strategy for the use of the product for filling bone defects is already planned according to local clinical practice, at the time of informed consent form signature, will be enrolled in this study. Thus, the decision for the choice of the surgical treatment, will not be influenced by the inclusion of the patient in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained prior to any study related procedure.
- •Male or female age ≥ 18 and ≤ 85 years.
- •Patients diagnosed with aseptic prosthetic loosening and scheduled for a one-stage hip or knee cementless or hybrid revision prosthesis implantation
- •Patients with an interval spacer and scheduled for hip or knee cementless or hybrid revision prosthesis implantation.
- •For those patients with an interval spacer, previous infection caused by microorganism(s) sensitive to gentamicin or vancomycin.
- •Able (in the Investigators opinion) and willing to comply with all study requirements
排除标准
- •Unable to give written informed consent.
- •Medically unfit for operative intervention.
- •Soft-tissue defects that prevent direct skin closure at revision surgery.
- •Females who are pregnant or lactating.
- •Females of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions may be included.
- •Known allergy to gentamicin or vancomycin (or related antibiotics).
- •Patients with previous nephro- or ototoxicity events due to aminoglycoside and/or vancomycin (or glycopeptides) use.
- •Presence of relevant contraindications as described in the EU CE mark Instructions for Use (IFU).
- •Myasthenia gravis.
- •Need of a fully cemented joint prosthesis.
- •Psychiatric or neurological disorders.
- •Active infection at the site of surgery as diagnosed by clinical and/or laboratory and/or imaging investigations.
研究组 & 干预措施
Treated with Device: Including sham
Treated with CERAMENTTM|G or V for filling of bone defects in the tibia and/or femur and/or the acetabulum.
干预措施: CERAMENT G V (Device)
Control
Control without CERAMENT device
结局指标
主要结局
incidence of post-surgical infection
时间窗: 12 months
次要结局
未报告次要终点