Abstract
Background and objectives: Patient-specific components (PSC) represent an innovative option for total knee arthroplasty (TKA) in advanced osteoarthritis. Their effectiveness, however, closely relies on accurate positioning. Our study investigates the accuracy achieved by means of an inertial-based extramedullary cutting guide and the postoperative clinical and radiographic outcomes. Methods and materials: This was a prospective, single-arm, pilot study involving patients undergoing primary TKA with YourKnee(TM) PSC. Femoral and tibial bone resections were performed using the Perseus inertial-based extramedullary cutting guide. Postoperative mechanical alignment and component positioning were assessed by computed tomography. Clinical outcomes were evaluated preoperatively and at 1, 3, 6, and 12 months postoperatively by main knee function and clinical outcome measures. Results: The study population included a small cohort (n= 12, four females/eight males, mean age 69 ± 5.65 years, mean BMI 25.7 ± 3.8 kg/m(2), KL grade > 3) with no control group. The mean absolute error between the planned and obtained Hip-Knee-Ankle angle was 1.36° ± 1.06 and within ±3° of all cases. Mean coronal alignment error was 1.87° ± 0.87 and 1.67° ± 0.75 for the femoral and tibial components, respectively. The mean sagittal alignment error was 1.89° ± 1.24 and 2.45° ± 0.87 for the femoral and the tibial components, respectively. Patients showed significant improvement in clinical and functional scores within the first 6 months: OKS increased from 20.64 ± 2.77 at the preoperative screening to 42.27 ± 4.34 (p < 0.0001), total KSS rose from 90.64 ± 17.25 to 169.36 ± 23.57 (p < 0.0001), and FJS reached 85.09 ± 17.14 at 6 months (p = 0.0031), indicating excellent functional recovery and forgotten joint effect. Knee ROM improved from 90.91° ± 11.14 to 110.36° ± 8.44 (p < 0.0001). After 6 months, outcome scores plateaued, suggesting an early stabilization of clinical benefits. No signs of radiolucency were detected on X-rays at 3- and 12-month follow-ups. Conclusions: The Perseus inertial-based extramedullary cutting guide used in combination with the YourKnee(TM) PSCs resulted in accurate intraoperative prosthesis positioning and significant improvements in clinical and functional outcomes at 6 months after surgery. Despite the small sample size and absence of a control group, the results suggest that such combination represents a viable option to conventional surgical instrumentation and current off-the-shelf prosthetic designs.