Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cost-utility ratio (ICER)
研究概览
简要总结
Chronic infection after total joint arthroplasty generally requires implant exchange. Two stage exchange is considered as the gold standard procedure. However, some authors suggest that one stage exchange may be as effective. No consensus exists in the current literature. The purpose of the study was to evaluate the cost of both strategies in comparison to their success rate.
详细描述
The primary criterion will be the cost-utility ratio (ICER) at 12 months follow-up.
The secondary criteria will be:
- quality of life;
- pain;
- persistence or recurrence of infection;
- occurrence of complications ;
- necessity for reoperation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age ≥ 18 years
- •Chronically infected total hip or knee arthroplasty requiring implant exchange
- •Affiliation to a social security system
- •Signed informed consent
- •Effective contraception during all study
排除标准
- •Repeat exchange after failure of a prior treatment for infection
- •Multiple implant infection
- •Infection due to mycobacteria or fungus
- •Pregnancy / Breast feeding
- •Patient under judicial protection
- •Impossibility to give informed consent for any reason
- •Participation to another study
研究组 & 干预措施
One stage exchange
One stage exchange of the chronically infected implant
干预措施: Exchange of total hip or knee arthroplasty on same time (Procedure)
Two stage exchange
Two stage exchange of the chronically infected implant
干预措施: Exchange of total hip or knee arthroplasty in two time (Procedure)
结局指标
主要结局
Cost-utility ratio (ICER)
时间窗: 12 months post-operative
次要结局
- Quality of life : EQ-5D questionnaire(12 months post-operative)
- Duration of whole treatment(12 months post-operative)
- cost of whole treatment(12 months post-operative)
- Pain : VAS score(12 months post-operative)
- Number of Persistence or recurrence of infection for all participants(24 months post-operative)
- Cost of complication treatment(12 months post-operative)
- Occurrence of complications(24 months post-operative)
- number of Necessity of reoperation for all patient(12 months post-operative)
- Operating time of all surgical procedures(procedure)
- Cost of repeat surgery(12 months post-operative)
- Quality of life : Oxford hip or knee questionnaires(12 months post-operative)