Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction

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 Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Procedure: ACL footprint localization after preoperative navigation executed by robotic arm; Procedure: ACL footprint localization after preoperative navigation executed by rmanual execution

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiakuo Yu, Tenured professor at Tsinghua; Phone Number: +86 13331031448; Email: yujiakuo@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10000
      • Recruiting
      • Beijing Tsinghua Chang Gung Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Preoperatively, the participant or guardian is willing and able to sign the informed consent form;
2. Patients aged 18 to 80 years (inclusive of 18 and 80 years), regardless of gender;
3. Patients who meet the diagnostic criteria for anterior cruciate ligament (ACL) tear and have no contraindications for implantation;
4. Patients with mature skeletons;
5. Good compliance and willingness and ability to participate in follow-up observations as required.

Exclusion Criteria:

• (1) Participants who have previously participated in other clinical studies of drugs, biological agents, or medical devices but did not meet the primary study endpoint within the specified timeframe; (2) Patients with a known allergy to one or more implanted materials; (3) Patients who are physically frail or unable to tolerate surgery due to other systemic diseases; (4) Presence of active infectious lesions in the knee joint or other parts of the body; (5) Obesity with a BMI > 35; (6) Patients with severe diabetes (acute complications of diabetes, preoperative random blood glucose ≥ 16.7 mmol/L with or without altered consciousness, such as diabetic ketoacidosis, suspected diabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis; chronic complications of diabetes leading to severe target organ damage requiring urgent treatment, such as acute cardiovascular and cerebrovascular diseases, renal insufficiency, severe vision loss due to retinal disease, intermittent claudication and ischemic symptoms due to peripheral vascular disease, diabetic foot); (7) Women who are pregnant or breastfeeding; (8) Drug users and substance abusers; (9) Patients who are mentally incapacitated or unable to understand the requirements for participating in the study, making cooperation difficult; (10) Those expected to have poor compliance, unwilling or unable to follow postoperative therapy and/or rehabilitation program instructions; (11) Other comorbid conditions that limit participation in the study, hinder compliance with follow-up, or affect the scientific integrity of the study; (12) Other conditions judged by the investigator to be unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Surgery after Preoperative Navigation; After planning the preoperative bone tunnel using the navigation system from Naton Robotics, robotic surgery will be performed on the day of the operation.	Procedure: ACL footprint localization after preoperative navigation executed by robotic arm; 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.
Active Comparator: Traditional Arthroscopic Surgery after Preoperative Navigation; After planning the preoperative bone tunnel using the navigation system from Naton Robotics, a senior physician will perform traditional arthroscopic surgery on the day of the operation.	Procedure: ACL footprint localization after preoperative navigation executed by rmanual execution; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation 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	One week post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	*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.	At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Collaborators: Nanyang Orthopedic Hospital; Weifang Yidu Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Actual): January 24, 2025
• Study Completion (Estimated): January 24, 2029

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: ACL reconstruction; Robotic Surgery; Surgical Navigation; Anterior cruciate ligament rupture; Bone Tunnel Footprint Localization Accuracy
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Rupture
• Other Study ID Numbers: 24751-0-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results of the Excel table for primary and secondary indicators, with personal information of each patient concealed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No