A Randomised Controlled Trial Comparing Gait in Fixed or Rotating Cementless Total Knee Arthroplasties
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Post-operative top downhill walking speed at 9-12 months.
研究概览
简要总结
The number of patients requiring knee replacements is increasing every year due to the combination of an aging population, increased patient expectancy, and rising levels of obesity. Therefore, newer implants, or design features, are introduced on a regular basis to try to improve patient outcomes. In 2013, DePuy Synthes launched the Attune Knee System to provide improved range of motion and address the unstable feeling some patients experience whilst performing everyday activities, such as going down stairs. The Attune cementless rotating platform knee was first implanted in September 2016. In 2004, the first Triathlon total knee designed by Stryker was implanted. Registry figures for both the Attune and Triathlon knees are promising with good implant longevity and outcomes.
There is only a small amount of literature available on the Attune knee as it is still a relatively new implant. Worldwide, the Triathlon is widely used and is also a well-established, successful implant used in the investigators' unit. This study will help to determine whether the Attune can improve patient outcomes in terms of gait analysis assessed by walking on a treadmill, patient reported outcome measures and X-ray outcomes when compared to the Triathlon knee. 90 patients who will undergo knee replacement and meet the inclusion criteria and agree to take part will be randomly placed in one of two groups to receive either the Attune or Triathlon knee implant.
详细描述
The number of patients requiring Total Knee Arthroplasty (TKA) is increasing every year due to the combination of an aging population, increased patient expectancy, and rising levels of obesity which accelerates the onset of osteoarthritis. Therefore, newer implants, or design features, are introduced on a regular basis in an attempt to incrementally improve patient outcomes. In 2013, DePuy Synthes launched the Attune Knee System to provide improved range of motion (ROM) and address the unstable feeling some patients experience whilst performing everyday activities, such as descending stairs. The Attune Knee System features a gradually reducing femoral radius, an innovative s-curve design of the posteriorly stabilised cam, a tibial base which can be downsized or upsized two sizes versus the insert, novel patella tracking, lighter innovative instruments, and a new polyethylene formulation. These implant properties could potentially produce improved gait and speed, better stability of the knee in deep flexion, reduced joint forces, better patella tracking, improved operative flexibility and efficiency, and implant longevity. The system currently comprises 14 femoral sizes, 10 tibial sizes and 5 patella options.
Registry figures regarding the Attune Knee System are promising. The 2020 figures from the National Joint Registry (NJR) for England, Wales, Northern Ireland and the Isle of Man, show that the cumulative revision rate for the Attune knee (fixed bearing) was 2.7% (95% confidence interval (CI), 2.32-3.17) at 5 years (i.e. implant survivorship at 5 years of 97.3%) out of 25,723 knee joints. The cumulative revision rate for the Attune knee (rotating platform (RP)) was 1.7% (95% CI, 1.17-2.50) at 5 years (i.e. implant survivorship at 5 years of 98.3%) out of 4,254 knee joints. Figures from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) 2020 Report show that the 5-year cumulative revision rate of the Attune Cruciate Retaining implant was 3.0% (95% CI, 2.7 to 3.5) out of 15,300 knees. The 5-year cumulative revision rate of the Attune Posterior Stabilized (PS) implant was 2.6% (95% CI, 2.1 to 3.3) out of 7,179 knees.
The Attune cementless Rotating Platform was first implanted in September 2016 and by February of 2021 over 22,000 have been implanted worldwide. There are only a small number of studies regarding the Attune implant due to its infancy. In 2004, the first Triathlon total knee (Stryker) was implanted. The Triathlon knee was designed to address the main reasons for revision surgery such as instability, patellofemoral tracking complications and loosening/osteolysis. There are cruciate-retaining, condylar-stabilising, posterior-stabilising and difficult primary options available. The single radius design allows for mid-flexion stability. Over 3 million Triathlon knees have been implanted worldwide.
Joint registries show a high rate of survivorship of the Triathlon with over 10 years of follow up. The 2020 figures from the NJR for England, Wales, Northern Ireland and the Isle of Man, show that the cumulative revision rate for the Triathlon was 2.2% (95% CI, 2.10-2.20) at 5 years (i.e. implant survivorship at 5 years of 97.8%) and 3.4% (95% CI, 3.18-3.56) at 10 years (i.e. implant survivorship at 10 years of 96.6%) out of 133,729 knee joints. Figures from the AOANJRR 2020 Report show that the cumulative revision rate of the Triathlon CR implant was 2.5% (95% CI, 2.4 to 2.7) at 5 years and 3.9% (95% CI, 3.7 to 4.2) at 10 years out of a total 50,402 knees. The cumulative revision rate of the Triathlon PS implant was 4.0% (95% CI, 3.6 to 4.5) at 5 years and 6.1% (95% CI, 5.5 to 6.9) at 10 years out of a total 8,755 knees.
To the investigators' knowledge, the only study to compare the Attune and Triathlon TKAs was a retrospective cohort analysis in 2018 using cemented components. The Attune implant was received by 1,178 patients, whilst the Triathlon implant was received by 5,707 patients. Patients who received the Attune TKA had a statistically significantly shorter length of stay and operating room time, were statistically significantly less likely to be discharged to a skilled nursing facility or other inpatient facility, and had statistically significantly lower total hospital cost than those who received the Triathlon implant.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged <65 years old who require a primary TKA for medial compartment osteoarthritis with a varus deformity.
- •On examination patients must have a pain free ROM of both hips, both ankles and the opposite knee. A history of mild pain in any of these lower limb joints that does not inhibit mobility is acceptable.
- •Must be able to walk at a pre-operative speed of at least 4 km/h (approximately 30 metres in 30 seconds).
- •Must be able to walk outside unaided or with no more than a walking stick.
- •Must be able to complete pre- and post-operative gait analysis.
- •Participants must have a functional level of spoken and written English and must have a smartphone or have access to a smartphone to complete the online questionnaires on REDCap and to take photographs for virtual assessment of ROM.
排除标准
- •Patients with valgus deformity of the knee.
- •Patients with previous lower limb arthroplasty.
- •Patients with previous lower limb open reduction and internal fixation (ORIF).
- •Patients who are American Society of Anaesthesiologists (ASA) grade 3 or higher.
- •Patients who are unable to adhere to the trial protocol (due to cognitive impairment, cannot speak English or for any other reason).
结局指标
主要结局
Post-operative top downhill walking speed at 9-12 months.
时间窗: 9-12 months
Post-operative top downhill walking speed at 9-12 months will be assessed via gait analysis.
次要结局
- Ground reaction forces in the vertical plane throughout the stance phase of the gait cycle.(9-12 months)
- Spatiotemporal gait parameter - step width(9-12 months)
- Spatiotemporal gait parameter - double support time(9-12 months)
- Pain Visual Analogue Score (VAS)(Pre-operation, post-operatively weekly from Week 1 to Week 6, 3 months and 12 months.)
- Gait symmetry at push off of the stance phase(9-12 months)
- 90-day complications(3 months)
- Spatiotemporal gait parameter - step length(9-12 months)
- Spatiotemporal gait parameter - stride length(9-12 months)
- EuroQoL-5D (EQ-5D-5L)(Pre-operation, 3 months and 12 months.)
- Feller's Patellar score(Pre-operation, 3 months and 12 months.)
- Ground reaction forces in the medio lateral plane throughout the stance phase of the gait cycle.(9-12 months)
- Ground reaction forces in the anterior posterior plane throughout the stance phase of the gait cycle.(9-12 months)
- Gait symmetry at mid-stance of the stance phase(9-12 months)
- Gait symmetry at weight acceptance (heel strike) of the stance phase(9-12 months)
- Oxford Knee Score (OKS)(Pre-operation, 3 months and 12 months.)
- Length of stay in hospital(Up to 4 months)
- EuroQoL-5D Visual Analogue Scale (VAS)(Pre-operation, 3 months and 12 months.)
- Spatiotemporal gait parameter - step time(9-12 months)
- Range of motion (ROM)(Pre-operation, 6 weeks, 3 months and 12 months.)
- Forgotten Joint Score (FJS)(Pre-operation, 3 months and 12 months.)