Clinical, Radiographic and Patient-reported Outcomes Associated With the Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 6
- 主要终点
- Count of Participants With Post-operative Mechanical Alignment
研究概览
简要总结
The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment, compared to TKA procedures using standard instruments. An additional study purpose is to document clinical and patient-reported outcomes in subjects receiving TKA with the Navio ™ system.
详细描述
Total Knee Arthroplasty (TKA) has become an effective and reliable treatment for arthritis of the knee (1). TKA is associated with low morbidity and mortality, and its effectiveness in reducing joint pain and improving range of motion is well established. In 2014, over 750,000 knee replacements were performed in the US (2).
A significant innovation in TKA has been the introduction of computer navigation and robotic-assisted surgery (3). One such technology is the Navio™ Robotic-assisted Surgical System. This system is a semi-autonomous image-free system. During the surgery, the surgeon maps the condylar landmarks and determines alignment indices to define the volume and orientation of bone to be removed. The tools to remove the bone and place the implants are controlled and manipulated by the surgeon with the guidance of a 3-dimensional digital map of the surgical surface.
Originally the Navio™ system was launched for use in unicondylar knee replacement only. To date, there have been over 1000 unicondylar knee replacement surgeries using the system. In 2017, Smith & Nephew Inc. expanded the indications for the Navio™ system to include TKA. The purpose of this multicenter, prospective study is to evaluate outcomes associated with this new indication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject requires primary total knee arthroplasty with the Journey II BCS or Cruciate-Retraining (CR) Systems due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis.
- •Subject was considered skeletally mature at the time of cone implantation (at least 18 years or older.)
- •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 IRB/EC approved informed consent form.
- •Subject plans to be available through two (2) years postoperative follow-up.
排除标准
- •Subject has BMI ≥
- •Subject has 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 is deemed by investigator to require a constrained or deep dish tibial insert.
- •Subject has inadequate bone stock to support the device (severe osteopenia, history of severe osteoporosis or severe osteopenia).
- •Subject has mental or neurologic condition(s) that may pre-empt the ability or willingness to restrict activities.
- •Subject is 80 years of age or older.
- •Subject is a prisoner or impending incarceration.
结局指标
主要结局
Count of Participants With Post-operative Mechanical Alignment
时间窗: 1 month
The number of participants achieving post-operative mechanical alignment within ±3 degrees from target with "Yes" indicating mechanical alignment was achieved and "No" indicating mechanical alignment was not achieved.
次要结局
- Hospital Length of Stay(During hospitalization, up to 6 days)
- Count of Participants With Implant Survival(2 years)
- Knee Society Score 2011(Baseline, 1 month, 6 months, 1 year, and 2 years)
- Quality of Life EQ-5D-5L(Baseline, 1 Month, 6 Months, 1 Year, 2 Years)
- Forgotten Joint Score (FJS)(Baseline, 1 month, 6 months, 1 year, 2 years)
- Operative Time(During surgery, up to 235 minutes)
- Radiographic Assessment - Anteroposterior (AP) Angle(Baseline, 1 month, 6 months, 1 year, and 2 years)
- Radiographic Assessment - Lateral Angle(Baseline, 1 month, 6 months, 1 year, and 2 years)
- Radiographic Assessment - Count of Participant Displacements(6 months)
- Radiographic Assessment - Displacement Measurement(6 months)