The ACL surgery robot features a preoperative navigation system that enhances the precision of bone tunnel placement. As the first dual-bundle reconstruction surgical robot developed in China, it integrates advanced technology to ensure accurate anatomical alignment. This multi-center study aims to evaluate the robot's effectiveness in improving surgical outcomes and reducing complications, demonstrating the potential of domestic innovations in orthopedic surgery. With its high accuracy in locating bone tunnel footprints, this robot represents a significant advancement in ACL reconstruction techniques. The trial is designed as a randomized controlled trial (RCT) led by a prospective randomized cohort. The study is initiated by Tsinghua University's long-term professor, Yu Jiakuo, and the product has received China's Class III clinical registration certificate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
Anterior cruciate ligament (ACL) reconstruction is performed using the preoperative navigation of Naton Robotics, followed by random assignment to either robotic surgery or traditional manual surgery. The difference between the two lies in whether the localization of the ACL footprint is performed by a human or by the robotic arm. The surgical technique is standardized as double-bundle reconstruction.
Anterior cruciate ligament (ACL) reconstruction is performed using the preoperative navigation of Naton Robotics, followed by random assignment to either robotic surgery or traditional manual surgery. The difference between the two lies in whether the localization of the ACL footprint is performed by a human or by the robotic arm. The surgical technique is standardized as double-bundle reconstruction.
Beijing Tsinghua Chang Gung Hospital.
Beijing, Beijing Municipality, China
RECRUITINGEvaluation of Bone Tunnel Footprint Localization Accuracy
The localization of bone tunnels is evaluated by comparing the deviation of each tunnel's position from its preoperative planned position at one week post-surgery (hereinafter referred to as "bone tunnel deviation value"). At one week post-surgery, each participant undergoes CT three-dimensional imaging of the knee joint on the surgical side, and the bone tunnel positions of the reconstructed ACL on the femur and tibia are measured. The measurement of the femoral tunnel uses the Bernard and Hertel method, measuring the ratio of the center point of the femoral tunnel relative to the Blumensaat line in terms of the horizontal length and height of the lateral femoral condyle. The measurement of the tibial tunnel uses the Stäubli and Rauschning method, measuring the ratio of the center point of the tibial tunnel in relation to the anterior-posterior and medial-lateral dimensions of the tibial plateau. Each research center has designated researchers review the images, and each tunnel cente
Time frame: One week post-surgery
Lysholm score
At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months, researchers assess the Lysholm score of the affected knee joint for each participant.The Lysholm knee score, published in 1982 and revised in 1985, has a total score of 100 points. This scale primarily evaluates daily living and athletic function, scoring eight aspects: limping, pain, support, locking, swelling, instability, stair climbing, and squatting. Among these, pain and instability together account for 50 points. The highest score is 100 points, while the lowest is 0 points.
Time frame: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
Relative Anterior Translation of the Tibia
At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months, researchers measure the anterior translation distance of the tibia for both the affected and healthy knee joints of the participants. Each side is measured three times, and the average of these three measurements is taken as the final measurement value for the anterior translation distance of the tibia. The relative anterior translation distance is calculated as the affected tibial anterior translation distance minus the healthy tibial anterior translation distance. Measurements are performed using the Kneelaxity arthrometer. Kneelaxity arthrometer is a device used to assess knee joint stability by measuring the anterior translation of the tibia relative to the femur, providing objective data on knee laxity and aiding in the evaluation of knee injuries and surgical outcomes.
Time frame: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
Knee Flexion and Extension Angle (Range of Motion)
At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months, researchers use a goniometer to measure the flexion and hyperextension angles of the affected knee joint. Each angle is measured three times, and the average of these three measurements is taken as the final measurement value for each angle.
Time frame: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months, researchers assess the IKDC score for the affected knee joint of each participant. Responses to each item are scored using an ordinal scale, where the answer representing the lowest functional level or highest symptom level receives 0 points. For example, the first item relates to performing the highest level of activity without significant pain; if the response is "I cannot perform any of the above activities due to knee pain," it receives 0 points; if the response is "very vigorous activities, such as jumping or rotating in basketball or soccer games," it also receives 0 points. The second item pertains to the frequency of pain over the past four weeks, where "constant pain" receives 0 points and "no episodes" receives 10 points. The scoring method for the IKDC subjective knee function evaluation form involves summing the scores of the above items (the 10th item, "What was your knee function b
Time frame: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
Tegner Knee Activity Scale
The researchers assess the Tegner Knee Activity Scale for the affected knee joint of each participant at preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months. Tegner Knee Activity Scale is a scoring system used to evaluate knee function and activity level. The scale scores patients based on the intensity of various activities they have been able to perform over a specific period. The score ranges from 0 to 10, where 0 indicates the inability to perform any activities, and 10 indicates the ability to engage in high-intensity sports, such as competitive-level activities. The Tegner score helps clinicians understand the functional status of the patient's knee and its impact on daily life and sports activities.
Time frame: *At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
Visual Analog Scale (VAS) Score
The researchers assess the VAS pain score for each participant at preoperative, 1 week postoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months, and calculate the improvement rate of the VAS score at 1 week, 6 weeks, and 3 months postoperative. Visual Analog Scale (VAS) is a subjective scale used to assess pain intensity. The VAS typically consists of a horizontal or vertical line, usually 10 centimeters long, with endpoints labeled "no pain" (0 points) and "worst imaginable pain" (10 points). Patients score their pain intensity by marking a point on this line.
Time frame: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
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