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

NCT06858930 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-03-05

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Nanyang Orthopedic Hospital

    collaborator UNKNOWN

  • Weifang Yidu Central Hospital

    collaborator UNKNOWN

  • Beijing Tsinghua Chang Gung Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-24
Primary Completion
2025-01-24
Completion
2029-01-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06858930 on ClinicalTrials.gov