Improved radiographic outcomes and decreased complications rate on the femoral side can be achieved by a novel designed whole-process robotic assisted hip system for total hip arthroplasty: a prospective randomized controlled trial.

Postoperative complications due to inaccurate prosthesis positioning are the main causes of early revision. The aim of this study was to (1) determine whether novel designed whole-process robotic assisted hip system allowed better radiographic outcomes and lower complications risk on the femoral side particularly stem subsidence compared to conventional THA, and to (2) identify the comparison of early clinical outcomes. 72 patients were initially enrolled and randomly divided into 2 groups. Finally, only 65 patients (31 RA-THAs, 34 C-THAs) were analyzed who had full 18-month follow-up data. Radiographic follow-up was performed at immediate and 6-month postoperatively, while clinical follow-up at 18-month postoperatively. Stem-related radiographic outcomes, femoral side complications and clinical scores were compared. The robotic arm allowed better radiographic outcomes of the femoral side, including a higher canal fill ratio (CFR) at B1 (P = 0.040), more neutral stem alignment (P = 0.029), lower subsidence (P = 0.023) and lower leg length discrepancy (LLD) (P = 0.010). In addition, low CFR at B1 (P = 0.001) was found the risk factor for subsidence. However, early clinical outcomes were consistent between both groups. The novel designed whole-process robotic assisted hip system covers both femoral and acetabular side operations. It allows accurate and safe manipulation of femoral side, including better stem-related radiographic outcomes and lower risk of subsidence and LLD. However, no advantage of robotic system in early clinical score was identified. Clinical trial registration number: ChiCTR2100044124.