Yukihide Minoda1, Kazue Hayakawa2, Keisuke Hagio3, Natsuo Konishi4, Tatsuya Tamaki5, Kentaro Iwakiri6. 1. Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan. 2. Department of Orthopaedic Surgery, Fujita Health University, Toyoake, Aichi, Japan. 3. Department of Orthopaedic Surgery, Osaka Minami Medical Center, Kawachinagano, Osaka, Japan. 4. Department of Orthopaedic Surgery, Akita Kousei Medical Center, Akita, Japan. 5. Department of Orthopaedic Surgery, Funabashi Orthopaedic Hospital, Funabashi, Chiba, Japan. 6. Department of Orthopaedic Surgery, Shiraniwa Hospital, Ikoma, Nara, Japan.
Abstract
BACKGROUND: An accelerometer-based portable navigation system was recently introduced to improve prosthetic alignment during total knee arthroplasty (TKA). The purpose of this multicenter prospective randomized controlled trial (RCT) was to evaluate the effects of this accelerometer-based portable navigation system for achieving more accurate alignment during TKA in the clinical setting. METHODS:One hundred patients with primary varus osteoarthritis of the knee were enrolled in this prospective RCT conducted in 5 hospitals. A navigation system was utilized in 50 patients (navigation group), and a conventional intramedullary femoral guide and an extramedullary tibial guide were utilized in 50 patients (conventional group). At 6 months postoperatively, weight-bearing radiographs were obtained of the whole operative leg. An experienced surgeon who was blinded to the treatment assignments then measured the alignment to 1 decimal place with use of computer software. Power analysis showed that 41 knees were required in each group. RESULTS: There were no complications as a result of the use of the accelerometer-based portable navigation system. Postoperative radiographs were obtained in 45 patients from each group. There were no significant differences in sex, age, height, body weight, body mass index, preoperative femorotibial angle, and operative time between groups. The absolute differences of the femoral prosthesis (p = 0.01), tibial prosthesis (p < 0.01), and hip-knee-ankle angle (p < 0.01) from a neutral mechanical axis were less in the navigation group compared with those in the conventional group. Alignment outliers (>2° away from the neutral mechanical axis) of the tibial prosthesis and hip-knee-ankle angle were less in the navigation group (9% and 27%, respectively) compared with those in the conventional group (31% and 49%; p = 0.01 and p = 0.04, respectively). CONCLUSIONS: To our knowledge, this is the first multicenter prospective RCT to evaluate an accelerometer-based portable navigation system. An accelerometer-based portable navigation system provides more accurate prosthetic and limb alignment in the coronal plane than conventional techniques, without extended operative time or an increased rate of complications. The results of this study may help orthopaedic surgeons decide whether or not to use an accelerometer-based portable navigation system. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
BACKGROUND: An accelerometer-based portable navigation system was recently introduced to improve prosthetic alignment during total knee arthroplasty (TKA). The purpose of this multicenter prospective randomized controlled trial (RCT) was to evaluate the effects of this accelerometer-based portable navigation system for achieving more accurate alignment during TKA in the clinical setting. METHODS: One hundred patients with primary varus osteoarthritis of the knee were enrolled in this prospective RCT conducted in 5 hospitals. A navigation system was utilized in 50 patients (navigation group), and a conventional intramedullary femoral guide and an extramedullary tibial guide were utilized in 50 patients (conventional group). At 6 months postoperatively, weight-bearing radiographs were obtained of the whole operative leg. An experienced surgeon who was blinded to the treatment assignments then measured the alignment to 1 decimal place with use of computer software. Power analysis showed that 41 knees were required in each group. RESULTS: There were no complications as a result of the use of the accelerometer-based portable navigation system. Postoperative radiographs were obtained in 45 patients from each group. There were no significant differences in sex, age, height, body weight, body mass index, preoperative femorotibial angle, and operative time between groups. The absolute differences of the femoral prosthesis (p = 0.01), tibial prosthesis (p < 0.01), and hip-knee-ankle angle (p < 0.01) from a neutral mechanical axis were less in the navigation group compared with those in the conventional group. Alignment outliers (>2° away from the neutral mechanical axis) of the tibial prosthesis and hip-knee-ankle angle were less in the navigation group (9% and 27%, respectively) compared with those in the conventional group (31% and 49%; p = 0.01 and p = 0.04, respectively). CONCLUSIONS: To our knowledge, this is the first multicenter prospective RCT to evaluate an accelerometer-based portable navigation system. An accelerometer-based portable navigation system provides more accurate prosthetic and limb alignment in the coronal plane than conventional techniques, without extended operative time or an increased rate of complications. The results of this study may help orthopaedic surgeons decide whether or not to use an accelerometer-based portable navigation system. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.