The Effect of ROSA®-Assisted Knee Arthroplasty on Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Oxford Knee Score
研究概览
简要总结
This is a randomized clinical study, in which 150 patients with end-stage osteoarthritis will be enrolled to ROSA®-assisted knee arthroplasty or conventional knee arthroplasty. Patients are recruited at Zuyderland Medical Center, enrolled pre-operatively and followed up for 12 months post-surgery. In- and exclusion criteria are stated below.
After recruitment, participants will be invited for a pre-operative visit. During this pre-operative visit Informed Consent is signed and completion of patient-reported outcome measures (PROMs) is checked. Additionally, measurements regarding body composition, strength and fitness and metabolic outcomes are performed. Participants will have a blood sample taken. Scans, adverse event and medication use will be confirmed. Participants will receive a ActiGraph for collecting data from physical activity. Of all patients, 72 will undergo additional measurements (gait, proprioception).
During surgery ROSA- and surgery-data will be collected. Post-operative participants will have a 6-weeks, 3-month and 12-month visit. During these visits pre-operative measurements are repeated.
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
- None
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
- •Eligible for primary TKA
- •age 40-90 years
- •Body-Mass-Index 18.5-50.0 kg/m2
- •American Society of Anaesthesiologists Class I-III
- •Willingness and capability to understand and follow protocol
排除标准
- •- Rheuma-/trauma-indicated knee arthroplasty
结局指标
主要结局
Oxford Knee Score
时间窗: 12-months post-operative
The Oxford Knee Score (OKS, best to worst 0-48) measures pain intensity and functional limitation of the knee during various activities. The questionnaire consists of 12 items. The maximum total score is 60 and corresponds with the highest pain intensity and functional limitation.
次要结局
- Stability of the knee(Immediately after the surgery)
- Pain Catastrophizing(Pre-operative, 3-months and 12-months post-operative.)
- Pain Sensitivity(Pre-operative, 3-months and 12-months post-operative.)
- Mobility(Pre-operative, 3-months and 12-months post-operative.)
- Duration of surgery(During surgery)
- Anesthesia(During surgery)
- Mobility of the knee(During and immediately after the surgery)
- Symptoms(Pre-operative, 3-months and 12-months post-operative.)
- Patient Survival(90-day and 1-year)
- Physical Activity(Pre-operative, 3-months and 12-months post-operative.)
- Body composition(Pre-operative, 3-months and 12-months post-operative.)
- Handgrip strength(Pre-operative, 3-months and 12-months post-operative.)
- Cost of procedure, implants(During Surgery)
- Physical strength(Pre-operative, 3-months and 12-months post-operative.)
- Quality of Life-Index(Pre-operative, 3-months and 12-months post-operative.)
- Blood loss(During surgery)
- Length of hospital stay(During in-patient stay for indicated surgery (up to 5 days))
- Knee implant position(Immediately after the surgery)
- Implant Survival(90-day and 1-year)
- Work Productivity and Activity Impairment(Pre-operative, 3-months and 12-months post-operative.)
- Complications(During in-patient stay for indicated surgery (up to 5 days))
- Mechanical axis of the leg.(3-months post-surgery)
- Metabolic Syndrome(Pre-operative, 3-months and 12-months post-operative.)
- Physical condition(Pre-operative, 3-months and 12-months post-operative.)
- Cost of procedure, personnel(During Surgery)
- Productivity(Pre-operative, 3-months and 12-months post-operative.)
- Medical consumption(Pre-operative, 3-months and 12-months post-operative.)
- Physical mobility(Pre-operative, 3-months and 12-months post-operative.)
- Work Ability Index(Pre-operative, 3-months and 12-months post-operative.)