The Functional Outcomes and Stability of Total Knee Replacement Design Concepts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change from Baseline Gait Kinematics at 1-Year
研究概览
简要总结
Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. However, up to 25% of patients are not entirely satisfied with their TKR. Patient dissatisfaction has been associated with inadequate functional outcome, especially during negotiation of stairs and slopes. This phenomenon, known as mid-flexion instability, is believed to be caused by excessive anterior-posterior motion of the implant during activities of daily living. This is characterised as a perception that the replaced knee is unsteady during certain tasks.
This study will compare the functional outcome of two implants that have been designed to provide patients with a functionally stable knee throughout its range of motion. The different design roles in preventing implant-related mid-flexion instability remain unknown. The functional outcome and stability of these implants will be tested non-invasively with 3D motion capture technology.
详细描述
This study will compare the functional outcome of two implants that have been designed to provide patients with a functionally stable knee throughout its range of motion. The different design roles in preventing implant-related mid-flexion instability remain unknown.
The Medacta GMK-Sphere implant consists of a fully congruent medial compartment which allows freedom of movement in the lateral compartment. Both femoral and tibial components are also available in a range of 13 sizes, allowing the surgeon to find a 'best fit' for each patient. These design features are aimed to mimic the movement of a natural healthy knee, potentially preventing implant-related mid-flexion instability.
The DePuy Synthes Attune implant design aims to provide patients with optimal functional outcome. The femoral component of this implant has a gradually reducing radius, and the tibial component an S-shaped post-cam mechanism. These features are designed to facilitate smooth movement and stability during flexion.
The comparative functional outcomes and stability in gait, and other activities of daily living has not been established for the two different TKR design concepts. Functional assessments will be carried out on TKR patients pre- and post-operatively. These assessments will non-invasively quantify the knee's stability, range of motion, strength as well as walking kinematics using 3D motion capture technology. As mid-flexion instability is most notable during downhill walking, patients will be required to walk downhill on a treadmill as part of this study, to better investigate the phenomenon of mid-flexion knee instability.
This study will not involve any invasive procedure in addition to the standard of care. As such, the research burden is minimal. The main ethical issue may be that patients will not be randomised into one of the two proposed groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of osteoarthritis of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon
排除标准
- •Inflammatory arthropathy
- •Patients requiring bone augmentation
- •Patients with collateral ligament incompetence
- •Valgus deformity >5 degrees.
研究组 & 干预措施
Medacta GMK Sphere
Half of the patients will be implanted with the Medacta GMK Sphere total knee arthroplasty
干预措施: Total knee arthroplasty (Device)
DePuy Synthes Attune
Half of the patients will be implanted with the DePuy Attune total knee arthroplasty
干预措施: Total knee arthroplasty (Device)
结局指标
主要结局
Change from Baseline Gait Kinematics at 1-Year
时间窗: Change from baseline at 1-Year
Gait of patients will be analysed pre-operatively, six-weeks post-operatively, and 1-year post-operatively by 3D motion capture technology. The change measured over time at 1-year will be the primary outcome.
次要结局
- Oxford Knee Score (Patient reported outcome measure of pain and function)(1 year post-operatively)
- Knee range of motion(1 year post-operatively)
- Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)(1 year post-operatively)
- Forgotten Joint Score (Patient reported outcome measure of awareness of knee)(1 year post-operatively)
- Patient Satisfaction (Pain/Hospital experience/functional ability/Surgery expectations)(1 year post-operatively)
- EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)(1 year post-operatively)
- Knee Strength(1 year post-operatively)
- Oxford Knee Score (Patient reported outcome measure of pain and function)(Pre-operatively)
- Oxford Knee Score (Patient reported outcome measure of pain and function)(6 weeks post-operatively)
- EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)(Pre-operatively)
- EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)(6 weeks post-operatively)
- Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)(Pre-operatively)
- Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)(6 weeks post-operatively)
- Forgotten Joint Score (Patient reported outcome measure of awareness of knee)(Pre-operatively)
- Forgotten Joint Score (Patient reported outcome measure of awareness of knee)(6 weeks post-operatively)
- Knee Strength(Pre-operatively)
- Knee Strength(6 weeks post-operatively)
- Knee range of motion(Pre-operatively)
- Knee range of motion(6 weeks post-operatively)