Medico-economic Interest of Single-use Ancillary Efficiency® in Fitting a GMK® Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Mean production cost of the surgical intervention (total knee arthroplasty) each arm, from an hospital perspective, using a micro-costing approach with items reported in a eCRF
研究概览
简要总结
Clinical studies on single-use ancillaries are still few; medico-economic benefits have to be assessed regarding their design and use.
A foreseeable increase in the number of surgeries in the future, tends to change the techniques and consequently to question the medico-economic context. Single-use ancillaries attempt to provide solutions to today's imperatives and could be relevant from a global medico-economic point of view.
For the moment, the conventional ancillaries for TKA are reused after sterilization.
The objective of the study is to improve the fluidity of the intervention process with cost control.
详细描述
After validation of the inclusion criteria, the surgeon will perform the randomization (1:1): single-use ancillary group or conventional ancillary group. Only the medical team and the block staff will be informed about the ancillary group, not the patient.
The use of the single-use ancillary does not induce any modification of the surgical technique for fitting a TKA. The surgical approach is unchanged and is specific to the surgeon. The appearance and use of the single-use ancillary are similar to the conventional ancillary except for the materials used for their design. Please note that a preliminary training at the beginning of the study will be carried out with the different investigators so that they can handle the different medical devices.
In total, 48 participants will be randomized. The medico-economics assessments will be performed for 20 patients (10 per group) by micro-costing to evaluate the preoperative, intraoperative and post-operative costs : reconditioning time, sterilization and transport time, preparation time and duration of intervention. The qualitative score of subjective assessment of the operator's perception of the ancillary measured during the intervention. The participants will evaluate their QOL by completing a questionnaire 3 month and 12 month postoperative. The safety parameters will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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 gonarthrosis or inflammatory arthrosis of the knee leading to surgical indication for total knee arthroplasty
- •Informed patient, able to understand the information, not opposing to participate this protocol
- •patient affiliate to social security
排除标准
- •Extra-joint Deformation needing bone associated gesture
- •Preoperative active or suspected infection
- •Local evolutive tumoral pathology
- •Medical history with bone gesture on concerned knee
- •Patient unable or refusing to give his consentement
- •Pregnant woman or in age to be pregnant without use any effective contraceptive method
- •Patient under maintenance of justice, tutelage or legal guardianship)
- •Presence of any family, sociological, political or geographic situation able to interfere with the protocol
结局指标
主要结局
Mean production cost of the surgical intervention (total knee arthroplasty) each arm, from an hospital perspective, using a micro-costing approach with items reported in a eCRF
时间窗: Day 0
Mean production cost of the surgical intervention in each arm is calculated thanks to 2 steps : 1) Quantification of health resources consumed during the surgical intervention (transport, cleaning, reconditionning sterilization of ancillaries, time spent by medical staff, nurses and materials used. (These data will be collected on a paper sheet and reported in a eCRF for 20 patients (10 per group)) ; 2) Valuation of health resources consumed with hospital cost accounting, mean wages, and purchase prices of materials.
次要结局
- Euroqol EQ-5D-5L quality-of-life questionnaire (5 questions with 5 possible answers)(3 months postoperative)
- qualitative score of surgeon's perception about ancillary (1-Excellent, 2-Good, 3- Difficult, 4- Unsure)(Day 0)
- weight of waste(Day 0)
- Incremental cost-utility ratio comparing single use ancillary versus reusable ancillary(1 year)
- clinical functional result in each group (Total KSS score)(1 year postoperative)
- clinical functional result in each arm(3 months postoperative)
- HKA angle(3 months postoperative)
- Number of Adverse events in each arm(1 year postoperative)