NCT01015365已完成不适用
Cementless One-stage Revision in Fast-track Setting of the Chronic Infected Hip Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 8
- 主要终点
- re-infection
研究概览
简要总结
The investigators hypothesise that cementless one-stage exchange revision surgery can be performed in patients with chronically infected hip replacement with substantial benefits for the patients, in terms of fast rehabilitation, low re-revision rates and good long term results.
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
- •Patient with clinical signs of infection for more than 4 weeks, arising from total hip arthroplasty (primary and revision), resurfacing hip arthroplasty or hemi-hip arthroplasty
- •Informed oral and written consent given
排除标准
- •Life expectancy under 2 years
- •Cognitive dysfunction
- •Pre-operative unwillingness to receive blood
- •Intravenous drug abuse
- •Alcoholism
- •Immunocompromised patients
- •Patients receiving immunosuppressive medication
- •Ongoing systemic inflammatory disease
- •Poorly regulated diabetes mellitus
- •Renal failure (requiring dialysis)
- •Acute systemic inflammatory response syndrome with proven infection (sepsis)
- •Signs of coexisting active long-term local infection (i.e. endocarditis)
- •Previous two-stage revision of hip arthroplasty due to ipsilateral chronic infection (regardless of symptom free interval) or contralateral chronic infection (within the last 2 years).
- •< 6 weeks since last surgery of the affected hip
- •If definition of infection is not fulfilled: infection defined as Culture positive: ≥ 3 positive intraoperative cultures (tissue biopsies a.m. Kamme-Lindberg) Culture negative: < 3 positive intraoperative cultures (tissue biopsies a.m. Kamme-Lindberg) + Chronic fistula with history of previous or existing secretion or Positive cultures in pre-operatively joint fluid aspiration with other clinical signs of infection or Visual pus or purulent fluid during exchange procedure with clinical signs of infection
研究组 & 干预措施
Surgical revision
Other
Surgical cementless One-stage revision of the chronic infected hip arthroplasty
干预措施: Cementless one-stage surgical revision (Procedure)
结局指标
主要结局
re-infection
时间窗: 2 years
次要结局
- Revision for other cause than infection(2 years)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
4 期
One-abutment One-time for Immediate Restoration Procedure in the Esthetic ZoneImplant Tissue FailureNCT04139512University of Liege18
尚未招募
Unknown
Implementation of a minimally invasive intervention (MINI) in specialist nephrology practices to strengthen person-centred care for patients with acute kidney injury (AKI), chronic kidney disease (CKD) and end-stage renal disease (ESRD)N17N18Acute renal failureChronic kidney diseaseDRKS00033063Zentrum für Palliativmedizin50
已完成
不适用
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEmAortic Valve StenosisAortic Valve DiseaseAortic Valve CalcificationNCT01383720Boston Scientific Corporation11
进行中（未招募）
不适用
Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy.Prostate CancerNCT03317990University College, London407
招募中
不适用
Pilot study using scaled preoperative radiographs of the normal side and accessible bony landmarks to restore the limb length of the fracture site during surgeryCTRI/2020/02/023593Amir Ratna Shakya