Does Personalized Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilized Knee Arthroplasty? A Prospective, Randomized Study Investigating the Clinical Utility of the NextAR Navigation System (NextAR).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score
研究概览
简要总结
This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.
详细描述
This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.
The aims of this study are:
- To determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment
- To determine whether NextAR system data contributes to improving patient outcomes and knee kinematics following TKR surgery, by providing greater flexion range that is equivalent to native knee motion.
- To assess clinical outcomes measured by standardised assessments, including radiographic evidence, the Forgotten Joint Score (FJS), the Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L) questionnaires.
- Determining the kinematics of the replaced knee as measured by 3D gait analysis.
According to study protocol, clinical evaluation is performed preoperatively and postoperatively at 6 weeks, 6 months, 1, and 2 years with the use of the Forgotten Joint Score (FJS), Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L).
CT scan is performed preoperatively and at 6-weeks after surgery, while X-ray assessment is performed at baseline and at the 1-year follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage osteoarthritis of the knee suitable for total knee arthroplasty.
- •Aged over 18 years.
排除标准
- •Unsuitable for TKR due to chronic infection, medical disease, inability to consent, inability to attend for post-operative follow-up, significant psychiatric issues, substance abuse issues
- •Previous reconstructive/fracture/arthroplasty surgery on affected knee
- •Active inflammation arthropathy
- •Significant extra articular deformity
- •Morbidly Obese (BMI >40)
- •Pregnant women
结局指标
主要结局
Determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score
时间窗: pre-op, 6 weeks, 6 months, 1 year, 2 years
To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score \- Forgotten Joint Score measures the patient's ability to forget about the joint as a result of successful treatment and is based on the premise that the best arthroplasty is one the patient forgets. This score goes from a minimum of 0 to a maximum of 100 points.
次要结局
- To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L(pre-op, 6 weeks, 6 months, 1 year, 2 years)
- To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score(pre-op, 6 weeks, 6 months, 1 year, 2 years)
- To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee(pre-op, 6 weeks, 6 months, 1 year, 2 years)
- Determining the kinematics of the replaced knee as measured by 3D gait analysis.(pre-op, 1 year)