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<p>The goal of the image-free VELYS Robotic-Assisted total knee arthroplasty is to maximize soft tissue kinematics and surgical precision during total knee arthroplasty (TKA). However, clinical evidence regarding its superiority over manual techniques remains equivocal. This is the first meta-analysis to synthesize the perioperative, functional, and radiographic performance of VELYS-assisted TKA (VELYS-TKA) compared with conventional TKA (C-TKA). A comprehensive literature search was performed in PubMed, Embase, and the Cochrane Library, as well as major Chinese databases including CNKI and Wanfang, to identify relevant comparative studies published up to January 2026. Our analysis focused primarily on patient-reported outcomes, including the KSS and VAS. Surgical factors and safety outcomes were also examined, covering range of motion, length of hospital stay, operative time, and the occurrence of complications, MUA, and revision surgery. Statistical computations were performed using STATA MP software (v18.0) Nine studies involving 138,441 patients were included. The meta-analysis indicated no significant differences between VELYS-assisted TKA and conventional TKA regarding KSS knee scores (MD = − 1.06; 95% CI: −3.20 to 7.52; <i>P</i> = 0.43), dynamic VAS scores (MD = 0.20; 95% CI: −0.65 to 0.25; <i>P</i> = 0.38), or operative time (MD = 3.73; 95% CI: −3.19 to 10.66; <i>P</i> = 0.29). The overall complication rate (RR = 0.92; 95% CI: 0.68 to 1.25, <i>p</i> = 0.93;) and revision rate (RR = 0.53; 95% CI: 0.10 to 2.86, <i>p</i> = 0.46;) were also similar. In contrast, patients undergoing VELYS-assisted TKA experienced faster early functional recovery, evidenced by statistically higher KSS functional scores (MD = 2.98; 95% CI: 2.02 to 3.94; <i>P</i> &lt; 0.001), lower static VAS scores (MD = − 0.40; 95% CI: −0.79 to − 0.01; <i>P</i> = 0.04), and shorter hospital stays (MD = − 0.45 days; 95% CI: −0.58 to − 0.33; <i>P</i> &lt; 0.001). However, the KSS functional score improvements remained below established minimally clinically important difference (MCID) thresholds. Current evidence indicates that VELYS-assisted TKA provides a safe and feasible alternative to standard TKA, offering potential for improved radiological precision, early recovery and a meaningful reduction in hospital stay. However, while these early trends are promising, the clinical magnitude of functional gains remains modest, and safety outcomes lack statistical robustness. Given the inherent constraints of the current evidence base, these findings should be regarded as preliminary, necessitating further validation through long-term randomized controlled trials.</p>

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Early clinical outcomes and preliminary radiological observations of VELYS-assisted versus conventional total knee arthroplasty: a meta-analysis

  • 期刊论文

  • 发表日期：

    2026年4月3日

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  • Changjiao Sun,
  • Qi Ma,
  • Xijiu Zhao,
  • Xiaofei Zhang,
  • Huimin Li,
  • Xu Cai

摘要

The goal of the image-free VELYS Robotic-Assisted total knee arthroplasty is to maximize soft tissue kinematics and surgical precision during total knee arthroplasty (TKA). However, clinical evidence regarding its superiority over manual techniques remains equivocal. This is the first meta-analysis to synthesize the perioperative, functional, and radiographic performance of VELYS-assisted TKA (VELYS-TKA) compared with conventional TKA (C-TKA). A comprehensive literature search was performed in PubMed, Embase, and the Cochrane Library, as well as major Chinese databases including CNKI and Wanfang, to identify relevant comparative studies published up to January 2026. Our analysis focused primarily on patient-reported outcomes, including the KSS and VAS. Surgical factors and safety outcomes were also examined, covering range of motion, length of hospital stay, operative time, and the occurrence of complications, MUA, and revision surgery. Statistical computations were performed using STATA MP software (v18.0) Nine studies involving 138,441 patients were included. The meta-analysis indicated no significant differences between VELYS-assisted TKA and conventional TKA regarding KSS knee scores (MD = − 1.06; 95% CI: −3.20 to 7.52; P = 0.43), dynamic VAS scores (MD = 0.20; 95% CI: −0.65 to 0.25; P = 0.38), or operative time (MD = 3.73; 95% CI: −3.19 to 10.66; P = 0.29). The overall complication rate (RR = 0.92; 95% CI: 0.68 to 1.25, p = 0.93;) and revision rate (RR = 0.53; 95% CI: 0.10 to 2.86, p = 0.46;) were also similar. In contrast, patients undergoing VELYS-assisted TKA experienced faster early functional recovery, evidenced by statistically higher KSS functional scores (MD = 2.98; 95% CI: 2.02 to 3.94; P < 0.001), lower static VAS scores (MD = − 0.40; 95% CI: −0.79 to − 0.01; P = 0.04), and shorter hospital stays (MD = − 0.45 days; 95% CI: −0.58 to − 0.33; P < 0.001). However, the KSS functional score improvements remained below established minimally clinically important difference (MCID) thresholds. Current evidence indicates that VELYS-assisted TKA provides a safe and feasible alternative to standard TKA, offering potential for improved radiological precision, early recovery and a meaningful reduction in hospital stay. However, while these early trends are promising, the clinical magnitude of functional gains remains modest, and safety outcomes lack statistical robustness. Given the inherent constraints of the current evidence base, these findings should be regarded as preliminary, necessitating further validation through long-term randomized controlled trials.