Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty: a Randomised Controlled Trial
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 leg alignment - Hip-knee-ankle axis (HKA axis)
研究概览
简要总结
REAL INTELLIGENCE™ CORI™ (CORI Surgical System) is a computer-assisted orthopedic surgical system. CORI Surgical System is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures.
CORI Surgical System is comprised of a console control unit, optical tracking camera, primary and secondary input displays (tablet and optional display monitor), and foot pedal. The CORI Surgical System software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module.
Yuanhua Orthopaedic Robotic Systems, KUNWU, is an open-platform robotic system that does not restrict surgeons in choosing the type of prosthesis implant. It is the only Orthopaedic Robotic System in Hong Kong registered with the HK Department of Health Medical Devices Control Office (MDCO) as an open platform system. Unlike other manufacturer's implant-based robots (closed systems), Yuanhua's objective is to provide maximum flexibility in choosing the best implant for each patient. Closed system robots not only impact the surgeon's choice of implant for an individual patient but also affect the hospital's implant purchases over multiple years without any negotiation power on pricing. This business model is often referred to as a "razor and razor blade" model.
The primary objective of this study is to evaluate the use of open and closed platform robotic-assisted TKA procedure in achieving post-operative leg alignment as compared to procedures using standard instruments. The secondary objective of this study is to assess the safety and performance of the robotic-assisted TKA procedure up to 12 months after surgery as compared to procedures using conventional manual instruments.
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
盲法说明
Subjects will be randomly assigned to the KUNWU navigational or CORI Surgical System or conventional manual instrumentation groups according to a balanced randomization procedure using a 1:1:1 allocation ratio. To ensure balanced group assignment, a block randomization schedule will be generated. All subjects who sign the ICF and meet all inclusion and exclusion criteria will be randomized in a 1:1:1 randomization allocation ratio. The block size should be sufficiently small to allow approximately equal allocation of subjects in each group should the study be terminated prematurely whilst also being large enough so as the next treatment cannot be guessed. The study is non-blinded.
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
- •Subject is a suitable candidate for a robotic-assisted TKA procedure
- •Subject requires a cemented TKA as a primary indication that meets any of the following condition:
- •Degenerative joint disease, including osteoarthritis
- •Rheumatoid arthritis
- •Avascular necrosis
- •Requires correction of functional deformity
- •Requires treatment of fractures that were unmanageable using other techniques
- •Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery)
- •Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form.
- •Subject plans to be available through two (2) year postoperative follow-up.
- •Applicable routine radiographic assessment is possible.
排除标准
- •Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (e.g. stems, augments, or custom made devices).
- •Subject has been diagnosed with post-traumatic arthritis.
- •Subject requires bilateral TKA.
- •Subject does not understand the language used in the Informed Consent Form.
- •Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU).
- •Subject has active infection or sepsis (treated or untreated).
- •Subject is morbidly obese with a body mass index (BMI) greater than
- •Subject is pregnant or breast feeding at the time of surgery.
- •Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.
- •Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
- •Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.
- •Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.
结局指标
主要结局
Post-operative leg alignment - Hip-knee-ankle axis (HKA axis)
时间窗: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
The primary objective of this study is to evaluate the use of open and closed platform robot in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments. The mechanical axis of the lower limb is calculated as the angle between the following two lines: the first line drawn from the centre of the femoral head to the centre of the knee joint, and the second line is drawn from the centre of the knee to the centre of the ankle joint. Record the correct angle in degrees for 'Leg Alignment on Standing long leg X-Ray - Provide angle and select one position Angle (neutral/ varus/ valgus)'. The angular deviation will be measured from the neutral position (180°).
次要结局
- Standard Radiographic Evaluation - Tibial slope(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
- Lateral View(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
- Standard Radiographic Evaluation - Femoral component rotation (FCR)(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
- Standard Radiographic Evaluation - Femoral coronal alignment (FCA)(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
- Standard Radiographic Evaluation - Tibial coronal alignment (TCA)(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
- Standard Radiographic Evaluation - Femoral sagittal alignment (FSA)(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
- Standard Radiographic Evaluation - Joint line distance(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
- Knee Society Score (KSS)(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
- Oxford Knee Score (OKS)(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
- Forgotten Joint Score (FJS)(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
- HEALTH ECONOMICS/QUALITY OF LIFE - EQ-5D-5L(pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery)
研究者
Prof. Tim-Yun Michael ONG
Clinical Assistant Professor
Chinese University of Hong Kong