Imageless handheld robotic-assisted total knee arthroplasty showed better clinical outcomes than conventional total knee arthroplasty: A randomized controlled trial with preliminary results at 1-year follow up

IF 1.6 4区医学 Q3 ORTHOPEDICS

Knee Pub Date : 2025-06-05 DOI:10.1016/j.knee.2025.05.028

Peter Bollars , Dinesh Nathwani , Ali Albelooshi , Max Ettinger , Frank Verheyden , Jan Mievis , Prashant Meshram , Martijn Schotanus

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引用次数: 0

Abstract

Background

Robotic-assisted total knee arthroplasty (RATKA) has been shown to achieve more accurate functional implant alignment than conventional instrumented TKA (CTKA). The aim of this randomized controlled trial was to assess differences in operative, clinical and functional outcome of RATKA compared with CTKA.

Methods

A total of 180 patients with osteoarthritis were included and randomized. Preoperative and 3- and 12-months postoperative patient-reported outcome measures (PROMs) and rate of serious adverse events (SAEs), requirement for ligament releases and implant sizes were compared.

Results

The preoperative baseline variables were not statistically different between RATKA and CTKA groups thus they were well matched. At 12 months follow up, RATKA had significantly better Oxford Knee Score (42.4 ± 5.4 vs. 38.7 ± 7.2, P < 0.001), KSS^function (81.2 ± 12.3 vs. 72.7 ± 15.1, P < 0.001), KSS^satisfaction (34.9 ± 5.2 vs. 31.2 ± 7.9, P < 0.001), EQ5D^index (0.883 ± 0.141 vs. 0.833 ± 0.144, P < 0.001), VAS pain^day (10.5 ± 12.5 vs. 21.5 ± 19.4, P < 0.001), and VAS pain^night (8.1 ± 11.3 vs. 18.9 ± 19.5, P = 0.029), Patient satisfaction (93.2 ± 8.3 vs. 79.8 ± 20.3, P < 0.001) and FJS-12 (73.2 ± 23.3 vs. 53.6 ± 29.0, P < 0.001) as compared with the CTKA group. The proportion of patients in the RATKA group requiring ligament release was lower (six (7%) vs. 45 (50%), P < 0.001) and those requiring a polyethylene thickness ≤ 10 (55 (62%) vs. 36 (40%), P < 0.004). There was no difference in the rate of SAEs between the two groups.

Conclusion

This randomized controlled trial found significantly higher PROMs in patients undergoing RATKA with no difference in SAEs as compared with CTKA. RATKA technology also showed reduced requirement for ligament release and smaller polyethylene sizes.

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无图像手持机器人辅助全膝关节置换术的临床效果优于传统全膝关节置换术：一项随机对照试验，1年随访初步结果

机器人辅助全膝关节置换术（RATKA）已被证明比传统的器械式全膝关节置换术（CTKA）实现更准确的功能性植入物对齐。这项随机对照试验的目的是评估RATKA与CTKA在手术、临床和功能结局方面的差异。方法随机选取180例骨关节炎患者。比较术前、术后3个月和12个月患者报告的结果测量值（PROMs）、严重不良事件发生率（SAEs）、韧带释放需求和种植体大小。结果RATKA组与CTKA组术前基线变量无统计学差异，吻合良好。在12个月的随访中，RATKA的牛津膝关节评分明显更好(42.4±5.4比38.7±7.2,P <；0.001), KSSfunction(81.2±12.3和72.7±15.1,P & lt;0.001), KSSsatisfaction(34.9±5.2和31.2±7.9,P & lt;0.001), EQ5Dindex(0.883±0.141和0.833±0.144,P & lt;0.001),脉管painday(10.5±12.5和21.5±19.4,P & lt;0.001),脉管painnight(8.1±11.3和18.9±19.5,P = 0.029),病人的满意度(93.2±8.3和79.8±20.3,P & lt;0.001)和FJS-12(73.2±23.3和53.6±29.0,P & lt;0.001)，与CTKA组比较。RATKA组中需要韧带松解的患者比例较低(6例（7%）vs. 45例（50%），P <；0.001)和那些要求聚乙烯厚度≤10(55（62%）对36 (40%),P <；0.004)。两组之间的SAEs发生率无差异。结论：该随机对照试验发现，与CTKA相比，RATKA患者的PROMs明显高于CTKA患者，SAEs无差异。RATKA技术也显示了韧带释放和更小聚乙烯尺寸的要求。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Knee 医学-外科

CiteScore

3.80

自引率

5.30%

发文量

171

审稿时长

6 months

期刊介绍： The Knee is an international journal publishing studies on the clinical treatment and fundamental biomechanical characteristics of this joint. The aim of the journal is to provide a vehicle relevant to surgeons, biomedical engineers, imaging specialists, materials scientists, rehabilitation personnel and all those with an interest in the knee. The topics covered include, but are not limited to: • Anatomy, physiology, morphology and biochemistry; • Biomechanical studies; • Advances in the development of prosthetic, orthotic and augmentation devices; • Imaging and diagnostic techniques; • Pathology; • Trauma; • Surgery; • Rehabilitation.