NCT06280352招募中不适用
Prospective Randomized Controlled Trial of Functionally Aligned Robotically Assisted Total Knee Arthroplasty vs Patient Specific Custom Made Total Knee Arthroplasty
Austrian Workers Compensation Board Styria4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Clinical Outcome using the Forgotten Joint Score
研究概览
简要总结
The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:
- Which implant/philosophy yields better clinical outcomes?
- Which implant/philosophy yields better satisfaction?
- Which system is more OR efficient? Participants will be followed for 2 years postoperatively.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- The patient is a male or non-pregnant female between the ages of 40 and 90 years
- •The patient requires a primary total knee replacement
- •Patient is deemed appropriate for a cruciate retaining knee replacement
- •The patient has a primary diagnosis of osteoarthritis (OA)
- •The patient has intact collateral ligaments
- •The patient is able to undergo CT scanning of the affected limb
- •The patient has signed the study specific, ethics-approved, informed consent document
- •The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations
排除标准
- •- The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint
- •Patient has had a previous osteotomy around the knee
- •The patient is morbidly obese (BMI > 41)
- •The patient has a deformity which will require the use of stems, wedges or augments
- •The patient has a varus deformity ≥ 15°
- •The patient has a valgus deformity >3°
- •The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
- •The patient is unable to speak German
- •The patient is pregnant
研究组 & 干预措施
Custom made Total Knee Arthroplasty
Experimental
Implant used is a patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)
干预措施: Custom made Total Knee Arthroplasty (Device)
Functionally aligned robotically assisted total knee arthroplasty
Active Comparator
Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker)
干预措施: Functionally aligned robotically assisted total knee arthroplasty (Device)
结局指标
主要结局
Clinical Outcome using the Forgotten Joint Score
时间窗: 6 weeks, 3 months, 6 months, 12 months, 24 months
Scale 0-100, higher score means better outcome
次要结局
- Revision rate(Minimum 2 years)
- Clinical outcomes using the Kujala anterior knee pain Score(preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Patient satisfaction(preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Visual analog pain (VAS) scale(preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Range of motion measurements (in degrees)(preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Radiographic data including radiolucent lines(preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Surgical and total theatre time(Perioperative phase)
- Opioid use(Intraoperative stay)
- Number of physiotherapy sessions(Intraoperative stay)
研究者
Antonio Klasan
Assistant Professor, MD, PhD, EMBA
Austrian Workers Compensation Board Styria
研究点 (4)
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