Robotized Computer Navigation Versus Conventional Technique in Total Knee Replacement. A Randomized, Clinical and Radiostereometric Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Radiostereometric migration
研究概览
简要总结
Navio is a new generation of computer navigation systems allowing intraoperative navigation of the bone cuts relative to both ligaments and skeletal axes, prior to bone removal. An improved accuracy is incorporated by the use of robotics in a burr for bone removal.
This study investigates whether this advanced technology leads to better clinical or radiostereometric results, by comparing one group operated with Navio to another group operated with conventional technique.
详细描述
Background:
The scientific foundation of total knee replacement (TKR) surgery is incomplete. As a national governor of joint replacements, the Norwegian Arthroplasty Register is obligated to strict regulations, demanding high levels of evidence for implants and instruments utilized by Norwegian surgeons. It is well known that 15-20% of patients with a TKR, are dissatisfied. Nevertheless, only a small proportion of these patients have revision surgery.
In this randomized, clinical trial we will use the Journey II BCS total knee system, with a more native anatomical design, intended to improve the kinematics and functional outcomes by mimicking a native knee, with respect to geometry and its interplay with the ligaments and soft tissue envelope of the knee (i.e. the biomechanics; stability, joint line, off-set, sizing etc.). To achieve an optimal placement of the implant, the surgeon needs to assess a lot of information (experience) during the surgical procedure. To secure this process, and to make sure all aspects are taken into account, with respect to an optimal positioning and ligament balancing, the computer navigation technique may offer valuable input, with further enhancement of the accuracy and precision using precision tools like the Navio from Smith & Nephew. The Navio system combines robotics and computer navigation, and represents the newest technology within surgical robotics and haptics. This trial is important in the mandatory evaluation process needed, before introducing new technology into orthopaedic surgery, on a larger scale.
Methods:
The surgeons involved have been trained at a wet lab, and on saw bones, before utilizing this tool in a live setting. After the introduction period, the training will continue in a clinical setting until the surgeons have operated at least 20 Navio assisted cases each, followed by a pilot study of 10 patients. All patients will be randomized to either Navio or Conventional technique.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are blinded as the Navio system will be switched on at all operations, the outcomes assessors, statisticians and co-researchers will not get access to the randomization information.
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Degenerative knee in need of a total knee arthroplasty
- •Recruited from the hospital's waiting list
- •Informed consent
排除标准
- •Severe systemic illness
- •Infections
- •Severe neurological dysfunction
- •Severe cancer disease
- •Severe incompensated heart failure
- •Severe incompensated lung disease
- •Previous fracture or deformity of the limb, making the use of an intramedullary rod impossible (same side hip or ankle implant is not to be excluded if the rod unaffectedly reaches more than the first half of the femoral canal)
研究组 & 干预措施
Navio
Using the new technology during surgery
干预措施: Navio (Procedure)
Conventional
Using the conventional surgical instruments
干预措施: Conventional (Procedure)
结局指标
主要结局
Radiostereometric migration
时间窗: 5 years
Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)
WOMAC high responders
时间窗: 5 years
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) high responders
时间窗: 3 months
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
WOMAC high responders
时间窗: 1 year
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
WOMAC high responders
时间窗: 2 years
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
Radiostereometric migration
时间窗: 1 year
Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)
Radiostereometric migration
时间窗: 2 years
Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)
次要结局
- EQ-5D(5 years)
- Knee society score (KSS)(5 years)
- Anchor questions(5 years)
- Visual analogue scale (VAS)(pre-op, 3 months, 1 year, 2 years, 5 years)
- Timed 40 meters walking test(1 year)
- Knee injury and osteoarthritis outcome score (KOOS)(5 years)
- Forgotten Joint Score (FJS)(5 years)
- Maximum climb-up test(1 year)
- Chair test 30 seconds(1 year)
- Knee injury and osteoarthritis outcome score (KOOS)(3 months)
- Knee injury and osteoarthritis outcome score (KOOS)(1 year)
- Knee injury and osteoarthritis outcome score (KOOS)(2 years)
- Knee society score (KSS)(3 months)
- Knee society score (KSS)(1 year)
- Knee society score (KSS)(2 years)
- EQ-5D(3 months)
- EQ-5D(1 year)
- EQ-5D(2 years)
- Forgotten Joint Score (FJS)(3 months)
- Forgotten Joint Score (FJS)(1 year)
- Forgotten Joint Score (FJS)(2 years)
- Maximum climb-up test(3 months)
- Anchor questions(2 years)
- Timed 40 meters walking test(3 months)
- Chair test 30 seconds(3 months)