Bollars Peter, Janssen Daniel, De Weerdt Wim, Albelooshi Ali, Meshram Prashant, Nguyen Thang D, Lacour Michael T, Schotanus Martijn G M
Department of Orthopedic Surgery, St. Trudo Hospital, Sint-Truiden, Belgium.
Department of Orthopedic Surgery, Mediclinic City Hospital, Dubai Healthcare City, Dubai, United Arab Emirates.
Knee Surg Sports Traumatol Arthrosc. 2023 Dec;31(12):5446-5452. doi: 10.1007/s00167-023-07590-x. Epub 2023 Oct 5.
Image-free handheld robotic-assisted total knee arthroplasty (RATKA) has shown to achieve desired limb alignment compared to conventional jig-based instrumented total knee arthroplasty (CTKA). The aim of this prospective randomized controlled trial (RCT) was to evaluate the accuracy of a semi-autonomous imageless handheld RATKA compared to CTKA in order to achieve the perioperative planned target alignment of the knee postoperatively.
Fifty-two patients with knee osteoarthritis were randomized in 1:1 ratio to undergo unilateral CTKA or an imageless handheld RATKA. A full-length lower limb CT-scan was obtained pre- and 6-week postoperative. The primary outcomes were radiologic measurements of achieved target hip-knee-ankle axis (HKA-axis) and implant component position including varus and external rotation and flexion of the femur component, and posterior tibial slope. The proportion of outliers in above radiographic outcomes, defined as > 3° deviation in postoperative CT measurements as compared to perioperative planned target, were also noted. Knee phenotypes were compared with use of the Coronal Plane Alignment of the Knee (CPAK) classification.
Baseline conditions were comparable between both groups. The overall proportion and percentage of outliers (n = 38, 24.4% vs n = 9, 5.8%) was statistically significant (p < 0.001) in favor of RATKA. The achieved varus-valgus of the femoral component (varus 1.3° ± 1.7° vs valgus - 0.1° ± 1.9°, p < 0.05) with statistically significant less outliers (0% vs 88.5%, p < 0.01), the achieved HKA-axis (varus 0.4° ± 2.1° vs valgus - 1.2° ± 2.1°, p < 0.05) and the posterior tibial slope (1.4° ± 1.1° vs 3.2° ± 1.8°, p < 0.05) were more accurate with RATKA. The most common postoperative CPAK categories were type II (50% CTKA vs 61.5% RATKA), type I (3.8% CTKA vs 23.1% RATKA) and type V (26.9% CTKA vs 15.4% RATKA). CPAK classification III was only found in CTKA (19.2%). Type VI, VII, VIII, and IX were rare in both populations.
The present trial demonstrates that an imageless handheld RATKA system can be used to accurately perioperatively plan the desired individual component implant positions with less alignment outliers whilst aiming for a constitutional alignment.
I.
与传统的基于夹具的全膝关节置换术（CTKA）相比，无影像手持式机器人辅助全膝关节置换术（RATKA）已显示出能实现理想的肢体对线。这项前瞻性随机对照试验（RCT）的目的是评估半自动无影像手持式RATKA与CTKA相比的准确性，以便术后实现膝关节围手术期计划的目标对线。
52例膝关节骨关节炎患者按1:1比例随机分组，分别接受单侧CTKA或无影像手持式RATKA。术前和术后6周进行全下肢CT扫描。主要结局指标为所实现的目标髋-膝-踝轴（HKA轴）的影像学测量以及植入物组件位置，包括股骨组件的内翻和外旋以及屈曲，还有胫骨后倾。还记录了上述影像学结果中异常值的比例，定义为术后CT测量值与围手术期计划目标相比偏差>3°。使用膝关节冠状面排列（CPAK）分类对膝关节表型进行比较。
两组的基线情况具有可比性。异常值的总体比例和百分比（n = 38，24.4% 对 n = 9，5.8%）在统计学上具有显著差异（p < 0.001），有利于RATKA。股骨组件实现的内翻-外翻（内翻1.3°±1.7°对外翻-0.1°±1.9°，p < 0.05），异常值在统计学上显著更少（0%对88.5%，p < 0.01），所实现的HKA轴（内翻0.4°±2.1°对外翻-1.2°±2.1°，p < 0.05）以及胫骨后倾（1.4°±1.1°对3.2°±1.8°，p < 0.05）在RATKA中更准确。最常见的术后CPAK类别为II型（CTKA为50%对RATKA为61.5%）、I型（CTKA为3.8%对RATKA为23.1%）和V型（CTKA为26.9%对RATKA为15.4%）。CPAK分类III型仅在CTKA中发现（19.2%）。VI型、VII型、VIII型和IX型在两组中均很少见。
本试验表明，无影像手持式RATKA系统可用于在围手术期准确规划所需的个体组件植入位置，使对线异常值更少，同时实现结构对线。
I级
