Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After Unicompartmental Knee Arthroplasty: a Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Static radiostereometric analysis (RSA)
研究概览
简要总结
The purpose of this study is to compare the percentage of early micromibilisation in unicompartmental knee arthroplasties in robot-assisted technique vs standard technique.
详细描述
The purpose of the study is to compare the percentage of early micromobilisation by static radiostereometric analysis (RSA) - primary outcome, gait analysis by inertial sensors to assess gait kinematics, and clinical perdormance measured by american knee society score (AKSS), oxford knee score (OKS), patient satisfaction score (PSS) and EQ5-D - secondary outcomes, among 2 groups of patients, of 25 individuals each, whi undergo medial unicompartmental knee arthroplasty.
The first group will be operated with a robot-assisted technique (with CORI Surgical System, Smith and Nephew, USA), the other with standard technique and the same implant (Journey UNI II, Smith and Nephew, USA).
The study will be a randomized and controlled blind superiority trial. Patients will not be informed about performing the surgery with one technique or the other in order to avoid potential biases in the data analysis.
Patients will be recruited at the orthoaedic and traumatologic 2nd clinica (head prof S. Zaffagnini) at IRCSS Istituto Ortopedico Rizzoli in Bologna, Italy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
At the research office of health professions at IRCCS Istituto Ortopedico Rizzoli in Bologna, Italy (coordinating centre), a block of 5 randomisation list using the site "www.randomisation.com" will be generated. A sequence of opaque envelopes will be set up with a sequential number on the outside. A label will be placed iside the envelope that will contain the words "CORI" or "STANDARD", according to the sequence indicated by the generated list. Envelopes will be always sealed at the Research Centre and the list kept under lock. The envelopes will be placed in a dedicated box and delivered to the studio manager.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unicompartmental Knee Arthrosis
- •Femoral condyles or medial tibial plate osteonecrosis
- •Healthy anterior cruciate ligament, posterior cruciate ligament and collateral ligaments of the affected knee
- •Post traumatic loss of joint configuration
- •Moderate varism deformity
- •Patients between 50 and 80 years old
- •Patients able to undergo a 2-year follow up after surgery
排除标准
- •Bi or Tricompartmental arthrosis
- •Unhealty anterior or posterior cruciate ligaments or collateral ligaments
- •Patients with neuromuscolar, degenerative and joint-related conditions
- •Patients younger than 50
- •Patients older than 80
- •Patients unable to undergo a 2-year follow up after surgery
研究组 & 干预措施
Robot-assisted UKA
Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via CORI surgical system (Smith & Nephew, USA).
干预措施: Robot-assisted UKA (Procedure)
Standard technique UKA
Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via standard technique.
干预措施: Standard technique UKA (Procedure)
结局指标
主要结局
Static radiostereometric analysis (RSA)
时间窗: 24 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Static radiostereometric analysis (RSA)
时间窗: Within 7 days from surgery, during hospitalisation
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Static radiostereometric analysis (RSA)
时间窗: 3 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Static radiostereometric analysis (RSA)
时间窗: 6 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Static radiostereometric analysis (RSA)
时间窗: 12 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
次要结局
- Gait analysis via inertial sensors(24 months)
- Oxford Knee Score(Pre-operatively, then at 3, 6, 12 and 24 months follow-up)
- American Knee Society score(Pre-operatively, then at 3, 6, 12 and 24 months follow-up)
- Patient Satisfaction Score(Pre-operatively, then at 3, 6, 12 and 24 months follow-up)
- EQ5-D questionnaire(Pre-operatively, then at 3, 6, 12 and 24 months follow-up)
- Gait analysis via inertial sensors(Within 7 days from surgery, during hospitalisation)
- Gait analysis via inertial sensors(6 months)
研究者
Stefano Zaffagnini
Head of Orthopaedics and Traumatology II Clinic
Istituto Ortopedico Rizzoli