Functional Comparison of Two Modern Designs of Total Knee Replacement - a Post-operative Comparator Gait Study Comparing Persona MC to Attune Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Knee extensor moment
研究概览
简要总结
This study aims to compare clinical and functional outcomes of a cohort of patients that have undergone a medial congruent TKR to a similar cohort of patients that have undergone a conventional TKR and a cohort of control participants. Our null hypothesis is that there will be no difference in the functional outcome (as assessed by gait analysis) between Attune and Persona MC TKR.
详细描述
This cross sectional, post-operative comparator gait study aims to compare the functional and patient reported outcomes of patients that have undergone a MC TKR to an age, gender, BMI, pre-operative diagnosis with satisfactory clinical outcome at one year (OKS > 34) matched cohort of patients undergone a modern generation TKR which utilises a gradually reducing radius of curvature on the femoral component with conventional polyethylene (Attune) to a TKR with gradually reducing radius of curvature on the femoral component but a medial congruent (MC) TKR design (Persona).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years and above*
- •Have undergone primary total knee replacement for either:
- •Osteoarthritis
- •avascular necrosis of the femur or tibia
- •Report an Oxford Knee Score greater than 34, obtained from usual clinical practice. OKS above 34 represents (range 0-48, high representing good outcome) a good outcome post-surgery.
- •Independent of study participation, patients received either commercially available Zimmer Biomet Persona MC bearing or DePuy Synthes Attune knee implants implanted in accordance with product labelling
- •1-5 years post TKR surgery
- •An adequate understanding of written and verbal information in English in order to provide informed consent and answer the study questionnaires* * Control participants will meet same inclusion criteria except no primary TKR and OKS will not be required
排除标准
- •History of infection in the replaced joint and/or other local/systemic infection that may affect the prosthetic joint
- •Skeletal immaturity
- •Neuropathic arthropathy
- •Osteoporosis/any loss of musculature or neuromuscular disease that compromises the affected limb
- •Severe instability secondary to the absence of collateral ligament integrity
- •Pregnancy - routine clinical practice ensures that all female patients are asked whether they are pregnant and can safely receive x-rays or surgery as per standard consent forms
- •Patient is a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
- •Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
- •Patients who are unable to give voluntary informed consent.
- •Patients who are unable to walk unaided (post-surgery).
- •** Control participants will meet the same exclusion criteria as TKR patients
- •Patients who suffer with cognitive impairment such as Parkinson's or Alzheimer's disease resulting in impaired mental capacity.
- •Patients who are unable to walk unaided.
- •Patients who suffer from dizzy spells or fainting episodes.
结局指标
主要结局
Knee extensor moment
时间窗: Average 3 years ± 2 years post-surgery
Maximum knee extensor moment during stair descent of the operated limb
次要结局
- Knee extension moments(Average 3 years ± 2 years post-surgery)
- Knee adduction moment(Average 3 years ± 2 years post-surgery)
- Forgotten Joint Score(Average 3 years ± 2 years post-surgery)
- Ground reaction forces(Average 3 years ± 2 years post-surgery)
- 2011 Knee Society Objective Knee Score(Average 3 years ± 2 years post-surgery)
- Proportion of patients able to complete each gait assessment(Average 3 years ± 2 years post-surgery)
- Gait velocity(Average 3 years ± 2 years post-surgery)
- Stance time(Average 3 years ± 2 years post-surgery)
- Knee flexion-extension range of motion(Average 3 years ± 2 years post-surgery)
- Sit to stand time(Average 3 years ± 2 years post-surgery)
- Knee angular velocity(Average 3 years ± 2 years post-surgery)
- Total OKS(Average 3 years ± 2 years post-surgery)
- Euro-QoL 5D (EQ-5D) index(Average 3 years ± 2 years post-surgery)
研究者
Hemant Pandit
Professor of Orthopaedic Surgery
University of Leeds