Comparative Outcomes of Robotic-Assisted Total Knee Arthroplasty: Cruciate-Retaining (CR) Versus Bi-Cruciate Stabilized (BCS) in a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-operative leg alignment - Standard Radiographic Evaluation
研究概览
简要总结
The global prevalence of osteoarthritis of the knee with total knee arthroplasty performed is projected to substantially rise in the near future. This phenomenon is also observed in Hong Kong in which more than 4000 elective total joint replacement surgeries were performed in 2021 and over 30,000 patients are on the waiting list where some regions would have to wait for a median of more than 4 years. REAL INTELLIGENCE™ CORI™ (CORI Navigation) is a computer-assisted orthopedic surgical navigation and blurring system. CORI Navigation is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures. CORI Navigation 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 Navigation software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module. Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA) was designed for more kinematically functional implants that better reconstruct natural knee kinematics for activities of daily living. Surgical implant designs that resect the cruciate ligaments has emerged to simplify implantation and reduce surgical difficulty. The improvement of the biomechanical properties mimicking the natural kinematics of both the BCS and CR TKA may provide an effective solution to patient's dissatisfaction and impaired functional outcomes after surgery.
详细描述
Arthritis is a clinical syndrome of joint pain accompanied by varying degrees of functional limitation and reduced quality of life. Two common etiologies of arthritis are degeneration of the joint, osteoarthritis (OA), and inappropriate inflammatory response, rheumatoid arthritis (RA). OA is characterized by loss of cartilage, remodeling of adjacent bone, and inflammation in the affected joint. RA is a progressive inflammatory disease that eventually causes systemic joint damage and disability. Post-traumatic arthritis is a form of osteoarthritis following an injury to a joint. Inappropriate joint biomechanics due to deformities is the main risk factor for OA. The joint biomechanics are directly affected by the malalignment of the lower extremities due to anatomical deformities. Varus deformity is an excessive inward angulation of the lower leg and results in a bowlegged appearance. It may cause an overloading and cartilage wear in the medial knee compartment, which could support a degeneration of the knee joint leading to OA.
As of 2010, there were approximately 250 million people globally with osteoarthritis of the knee joint (3.6% of the global population). The prevalence was higher in females than in males. Initial treatment of arthritis may include physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and corticosteroids which can be taken orally or by injection.
Avascular necrosis (AVN) has several etiologies but fundamentally results from a decrease in blood flow to the affected bone, leading to cellular death. Studies have reported a 3.4% and 9.4% incidence of spontaneous osteonecrosis in persons older than 50 and 65 years of age, respectively. Initial treatment of AVN may include medication, stretching, and avoiding walking on the affected leg.
Complex epiphyseal fractures around the knee joint involve the distal femur or proximal end of the tibia. The management of these fractures, especially in elderly patients, is challenging. When the damage to the joint is advanced or available conservative treatment options are exhausted, knee arthroplasty is considered the most effective treatment for patients with any of these indications.
Total knee arthroplasty (TKA) is a highly successful and frequently performed surgical treatment to reduce disability caused by end-stage osteoarthritis and other conditions affecting articular cartilage. Technical outcomes for TKA are excellent, with favorable postoperative health-related quality of life. Also, survivorship of primary knee replacements is excellent with reported survivorship of 82.3% at 25 years. TKA has traditionally been indicated in the elderly population with relatively sedentary lifestyles, but more active, younger patients (<55) are receiving TKA due to the desire for a pain-free, active lifestyle with the demand projected to continue to increase for this group. A recent systematic review has shown that functional outcomes are similar in this population compared to elderly patients with no increase in the burden of revision.
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 robotic assisted Cruciate-Retaining (CR) or Bi-Cruciate Stabilized (BCS) TKA procedures groups according to a balanced randomization procedure using a 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 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.
研究组 & 干预措施
Robotic assisted Cruciate-Retaining (CR) TKA procedures
Patients who underwent Cruciate Retaining (CR) total knee arthroplasty (TKA)
干预措施: Robotic assisted Cruciate-Retaining (CR) TKA procedures (Procedure)
Robotic assisted Bi-Cruciate Stabilized (BCS) TKA procedures
Patients who underwent Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA)
干预措施: Robotic assisted Bi-Cruciate Stabilized (BCS) TKA procedures (Procedure)
结局指标
主要结局
Post-operative leg alignment - Standard Radiographic Evaluation
时间窗: pre-operatively and 6 weeks, 12 weeks，12months and 24 months after surgery
The leg alignment should be measured from an antero-posterior (A/P) view standing weight bearing full leg ('long leg') x-ray. The following axes shall be identified: * Mechanical Axis of the femur: Axis from the center of the femoral head to the center of the distal femur. * Mechanical Axis of the tibia: Axis from the center of the proximal to the center of the distal tibia. Standard radiographic evaluation on antero-posterior (A/P) and lateral (L) views shall be performed 12\&24 months after surgery in order to identify any radiographic observations such as radiolucent lines around the implant components. The presence of radiolucent lines, osteolysis \& implant migration shall be recorded.
次要结局
- 2011 Knee Society Score(pre-operative visit and 6 weeks, 6 months, 12 months, and 24 months after surgery)
- EQ-5D-5L(pre-operative visit as well as 6 weeks, 6- , 12 - and 24-months after surgery.)
- Oxford Knee Score(pre-operative visit and 6 weeks, 6 months, 12 months and 24 months after surgery)
- Forgotten Joint Score(pre-operative visit and 6 weeks, 6 months, 12 months, and 24 months after surgery)
- Knee Injury and Osteoarthritis Outcome Score(pre-operative visit and 6 weeks, 6 months, 12 months, and 24 months after surgery)
- The Western Ontario and McMaster Universities Osteoarthritis Index(pre-operative visit and 6 weeks, 6 months, 12 months, and 24 months after surgery)
- Gait analysis(pre-operative visit as well as 6 weeks, 6- , 12 - and 24-months after surgery)
- Proprioception(pre-operative visit and 6 weeks, 6 months, 12 months, and 24 months after surgery)
研究者
Prof. Tim-Yun Michael ONG
Clinical Assistant Professor
Chinese University of Hong Kong