NCT04600583进行中（未招募）不适用
A Prospective, Randomized, Controlled Trial of Mechanical Axis With Soft Tissue Release Balancing vs Functional Alignment With Bony Release Balancing in Total Knee Replacement - A Study Using Stryker Mako Robotic-Arm Assisted Technology®.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- Joint feeling and Forgotten Joint Score
研究概览
简要总结
This study is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. All patients will be treated with the same knee system, implanted using MAKO robotic-arm assisted technology.
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 80 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 40-80 years.
- •The patient requires a primary total knee replacement and is indicated for robotic-assisted surgery.
- •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 ≥ 40).
- •The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
- •The patient has a varus/valgus deformity ≥ 15°.
- •The patient has a fixed flexion deformity ≥ 15°.
- •The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- •The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- •The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- •Patient has a cognitive impairment, an intellectual disability or a mental illness.
- •The patient is pregnant.
- •The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
结局指标
主要结局
Joint feeling and Forgotten Joint Score
时间窗: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months
To evaluate differences in joint feeling assessed via the Forgotten Joint Score. This newly-developed 12-item score ranges from 0 to 100 and assesses how aware recipients are of their joint in everyday life. Higher scores indicate a good outcome i.e. a high degree of forgetting the joint. For the purpose of this study a change in score of 14 points for the Forgotten Joint Score has been identified.
次要结局
- Function and The International Knee Society Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months)
- Early pain(In-patient setting (< 5 days post-operation), Post-operative - 6 weeks and 6 months)
- Function and Oxford Knee Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
- Pain and Knee Injury and Osteoarthritis Outcome Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
- Pain and Oxford Knee Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
- Pain and The International Knee Society Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months)
- Pain and Visual Analogue Scale(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
- Function and Knee Injury and Osteoarthritis Outcome Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
- Health related quality of life and Euro-Qol (EQ-5D-3L)(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
- Blood loss(Intra-operative)
- Adjustments to balance(Intra-operative)
- Satisfaction and Net Promoter Score(Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months)
- Ability to reach target knee balance as assessed by alignment angles and gaps(Pre-operative (2 weeks prior to surgery), intra-operative, Post-operative - 6 weeks, 12 months and 24 months)
- Early function(In-patient setting (< 5 days post-operation))
研究者
研究点 (2)
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