Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- operative time
研究概览
简要总结
This prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial unicondylar knee arthroplasty
详细描述
this prospective cohort study was conducted between 1st June 2015 and 1st July 2018 at Bhumibol Adulyadej Hospital, Bangkok, Thailand. A total of 33 medial compartment OA knee patients were randomly allocated to MAKO or NAVIO robotic assisted UKA. The outcomes assessed were intra-operative outcomes (operative time, blood loss) and postoperative outcomes (function, complications and revision) at 1 year after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients were those deemed suitable for unicondylar knee arthroplasty surgery
- •patients who could give informed consent
- •patients who willing to attend the prescribed follow-up.
排除标准
- •Patients who have medial osteoarthritis knee with following condition:
- •Ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency).
- •Inflammatory arthritis
- •A deformity requiring augmentation
- •Neurological movement disorders
- •pathology of the feet, ankles, hips, or opposite knee causing significant pain or gait alterations
- •Patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.
研究组 & 干预措施
MAKO robotic assisted UKA
image base (MAKO) robotic assisted UKA
干预措施: MAKO assisted unicondylar knee arthroplasty (Procedure)
NAVIO robotic assisted UKA
imageless (NAVIO) robotic assisted UKA
干预措施: NAVIO assisted unicondylar knee arthroplasty (Procedure)
结局指标
主要结局
operative time
时间窗: 1 day
operative time in minutes the higher value of blood loss is worse outcome
calculated total blood loss
时间窗: 1 day
total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin
次要结局
- post operative complications(12 months)
研究者
Jatupon Kongtharvonskul
principle investigator
Ramathibodi Hospital