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Purpose <p>This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system.</p> Methods <p>144 patients who underwent primary TKA were enrolled in this prospective, multicenter RCT conducted in three hospitals. five patients were lost to follow-up at six weeks after surgery. Therefore, 139 patients (73 in the RA TKA group and 66 in the CI TKA group) remained in the final analysis. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes included coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).</p> Results <p>At 12 weeks postoperatively, we found the rate of radiographic inliers was significantly higher in the RA TKA group (90.4% vs. 59.1%; <i>p</i> &lt; 0.05). The difference between planned and postoperative frontal femoral component (FFC) angle, frontal tibia component (FTC) angle and lateral femoral component (LFC) angle are significantly smaller in the RA TKA group (<i>p</i> &lt; 0.05). The operation time was significantly longer in the RA TKA group than in the CI TKA group (133.01 vs. 92.33&#xa0;min; <i>p</i> &lt; 0.05). There was no significant difference in blood loss, 12-week ROM, 12-week postoperative functional outcomes and satisfaction evaluated by KSS and WOMAC scores. There were no AEs or SAEs that were determined to be “related” to the robotic system.</p> Conclusion <p>The novel robot assisted TKA is safe and more precise in bone resection and implant positioning as demonstrated in this trial.</p>

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Better radiological outcomes but equal clinical function of a novel knee arthroplasty robot system: a prospective randomized controlled trial

  • 期刊论文

  • 发表日期：

    2025年4月23日

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  • Xiao Geng,
  • Ziyang Dong,
  • Jiazheng Chen,
  • Mengqiang Tian,
  • Yongqing Wang,
  • Yiming Ren,
  • Zhihui Zhao,
  • Yipu Zhang,
  • Xinguang Wang,
  • Cheng Wang,
  • Zijian Li,
  • Hua Tian

摘要

Purpose

This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system.

Methods

144 patients who underwent primary TKA were enrolled in this prospective, multicenter RCT conducted in three hospitals. five patients were lost to follow-up at six weeks after surgery. Therefore, 139 patients (73 in the RA TKA group and 66 in the CI TKA group) remained in the final analysis. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes included coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).

Results

At 12 weeks postoperatively, we found the rate of radiographic inliers was significantly higher in the RA TKA group (90.4% vs. 59.1%; p < 0.05). The difference between planned and postoperative frontal femoral component (FFC) angle, frontal tibia component (FTC) angle and lateral femoral component (LFC) angle are significantly smaller in the RA TKA group (p < 0.05). The operation time was significantly longer in the RA TKA group than in the CI TKA group (133.01 vs. 92.33 min; p < 0.05). There was no significant difference in blood loss, 12-week ROM, 12-week postoperative functional outcomes and satisfaction evaluated by KSS and WOMAC scores. There were no AEs or SAEs that were determined to be “related” to the robotic system.

Conclusion

The novel robot assisted TKA is safe and more precise in bone resection and implant positioning as demonstrated in this trial.