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

NCT06858930 | Recruiting

• 1 other identifier: 24751-0-02
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Anterior cruciate ligament rupture; ACL reconstruction; Surgical Navigation; Robotic Surgery; Bone Tunnel Footprint Localization Accuracy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Lysholm score

  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.

• Knee Flexion and Extension Angle (Range of Motion)

  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.

• Tegner Knee Activity Scale

  *At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.

Study Arms (2)

Robotic Surgery after Preoperative Navigation

EXPERIMENTAL

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

Traditional Arthroscopic Surgery after Preoperative Navigation

ACTIVE COMPARATOR

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

Interventions

ACL footprint localization after preoperative navigation executed by robotic arm PROCEDURE

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.

Robotic Surgery after Preoperative Navigation

ACL footprint localization after preoperative navigation executed by rmanual execution PROCEDURE

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.

Traditional Arthroscopic Surgery after Preoperative Navigation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• Nanyang Orthopedic Hospital: collaborator
• Weifang Yidu Central Hospital: collaborator

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital.

Beijing, Beijing Municipality, 10000, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Jiakuo Yu, Tenured professor at Tsinghua

CONTACT

+86 13331031448; yujiakuo@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Throughout the clinical study, efforts should be made to keep participants blinded; however, since participants can learn which surgical instruments they used by obtaining a copy of their hospital records upon discharge, the blinding in this clinical study should be maintained as much as possible until the participants automatically unblind themselves.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Robotic Surgery after Preoperative Navigation vs Traditional Arthroscopic Surgery after Preoperative Navigation

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: January 24, 2025
• Primary Completion: January 24, 2025
• Study Completion (Estimated): January 24, 2029
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)