NCT05435690进行中（未招募）不适用
Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty
GCS Ramsay Santé pour l'Enseignement et la Recherche2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2023年1月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- KSS M12
研究概览
简要总结
Evaluation of a new navigation system in computer-assisted total knee arthroplasty.
详细描述
Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
The patient will be evaluated during 3 visits: inclusion D0 (before arthroplasty), M3 (intermediate visit 3 months after arthroplasty) and M12 (final visit 12 months after arthroplasty).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult man or woman who has signed the informed consent for participation in the study,
- •Patient with primary uni or bilateral gonarthrosis
- •For whom an indication for total knee arthroplasty has been given
排除标准
- •History of fracture, arthroplasty or osteotomy of the knee
- •Severe preoperative laxity warranting a constrained prosthesis
- •Inflammatory rheumatic disease or any other progressive concomitant condition that may impact on the patient's functional prognosis
- •Traumatic articular or extra-articular deformities of the lower limb
- •Neurological disease, after-effects of a stroke
- •Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
- •Patient not affiliated to the French social security system
- •Patient under legal protection, guardianship or curatorship
- •Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months
结局指标
主要结局
KSS M12
时间窗: Month 12
Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score
次要结局
- KOOS JR M12(Month 12)
- FJS M3(Month 3)
- Hospitalization duration(Month 1)
- KSS M3(Month 3)
- EQ-5D M3(Month 3)
- EQ-5D M12(Month 12)
- FJS M312(Month 12)
- Surgery duration(Day 0)
- Postoperative outcome predictive factor(Month 1)
- KOOS JR M3(Month 3)
- Lower limb alignment(Month 12)
- Safety analysis(Month 12)
研究者
研究点 (2)
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