NCT04095637招募中不适用
A Prospective Randomised Control Trial of Mako Medial Unicondylar Knee Arthroplasty Versus Jig-based Oxford Unicompartmental Knee Arthroplasty With Navigation Contro
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Accuracy of component positioning
研究概览
简要总结
The overall aim of this prospective, randomised, single-blinded, controlled trial is to compare clinical outcomes and accuracy of implant positioning in Mako robotic UKA versus jig-based Oxford UKA with navigation control. Patients receiving the Mako robotic UKA (Stryker Ltd) will form the investigation group and those undergoing the jig-based Oxford UKA (Zimmer-Biomet Ltd) with navigation control will form the control group.
The primary objective in this study is to compare accuracy of component positioning as assessed by postoperative low radiation dose CT scan between conventional Jig-based Oxford UKA with navigation control and Mako robotic UKA.
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)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patient has medial unicompartmental knee osteoarthritis requiring primary UKA
- •Patient and Surgeon are in agreement that UKA is the most appropriate treatment
- •Patient is fit for surgical intervention following review by surgeon and anaesthetist
- •Patient is between 40-80 years of age at time of surgery
- •Gender: male and female
- •Patient must be capable of giving informed consent and agree to comply with the postoperative review program
- •Patient must be a permanent resident in an area accessible to the study site
- •Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken
排除标准
- •• Patient is not suitable for primary UKA e.g. multi-compartmental knee osteoarthritis, anterior cruciate ligament rupture
- •Patient is not medically fit for surgical intervention
- •Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral UKA
- •Patient is immobile or has another neurological condition affecting musculoskeletal function
- •Patient is less than 40 years of age or greater than 80 years of age
- •Patient is already enrolled on another concurrent clinical trial
- •Patient is unable or unwilling to sign the informed consent form specific to this study
- •Patient is unable to attend the follow-up programme
- •Patient is non-resident in local area or expected to leave the catchment area postoperatively
结局指标
主要结局
Accuracy of component positioning
时间窗: 6 weeks post-op
Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan
次要结局
- Lower limb alignment(Pre-op then 6 weeks, 6 months, 1 and 2 years post-op)
- Femoral implant alignment(Pre-op then 6 weeks, 6 months, 1 and 2 years post-op)
- Range of movement(Pre-op then 6 weeks post-op, 6 months post-op, one year post-op; 2 years post-op)
- Operating time(Intraoperative)
- Tibial implant alignment(Pre-op then 6 weeks, 6 months, 1 and 2 years post-op)
- Oxford Knee Score (OKS)(Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- Short form SF-12(Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)(Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- Time to discharge(6 weeks post op)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- Knee injury and Osteoarthritis Outcome Score (KOOS) Osteoarthritis Outcome Score (KOOS)(Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- Mobilisation distance (metres)(Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- Use of mobility aids(Pre-op then 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- Complications(during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years)
研究者
研究点 (2)
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