CAS vs Tecnica Chirurgica Standard Nella Protesi Totale di Ginocchio: Confronto Dei Risultati Clinico-funzionali
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Knee Society Score (KSS)
研究概览
简要总结
The study involves the enrollment of a sample of patients with indication for total knee replacement surgery in order to compare the conventional surgical technique currently used in the reference departments with the surgical technique with the aid of computer-assisted navigation.
The comparison between the two techniques will be performed in terms of clinical-functional results, perioperative bleeding and healthcare costs (surgical time, hospital stay).
The research protocol involves the participation of 160 total patients divided into two groups, of 80 patients each, by type of surgical technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary or secondary gonarthrosis with indication for knee arthroplasty with primary implant
- •Males and females aged ≥ 45
- •Willingness to participate in the study
- •Acquisition of informed consent to participate
排除标准
- •Patients who are not capable of understanding and willing, and therefore unable to express consent to participation in the study
- •Patient refusal to participate in the study and to sign the informed consent
- •Nickel allergy (suspected or diagnosed)
- •Pregnant women or women of childbearing age who cannot exclude pregnancy
研究组 & 干预措施
conventional total knee arthroplasty surgery
干预措施: conventional total knee arthroplasty (Procedure)
computer-assisted total knee arthroplasty surgery
干预措施: computer-assisted total knee arthroplasty (Procedure)
结局指标
主要结局
Knee Society Score (KSS)
时间窗: From enrollment to 12 months post-operative followup
Knee Society Clinical Rating System (KSS): there are 2 section, "Knee Score" section and a "Functional Score" section; both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: from enrollment to 12 months post-operative followup
Set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The score measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations.
NRS scale
时间窗: from enrollment to 12 months post-operative followup
Numeric Pain Rating scale is a unidimensional measure of pain in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. 0 = no pain, 10 = worst pain possible
次要结局
- surgical time(the day of surgical procedure)
- complications(from surgery to 12 month follow-up)
- delta hemoglobin(from surgery to discharge, up to 4 weeks)
- Transfusions(from surgery to discharge, up to 4 weeks)
- hospital stay(from surgery to discharge, up to 4 weeks)