A Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments

30 patients with the first rupture of the cruciate ligament were divided into two groups as 1:1. Experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction. Control group will be treated with conventional reconstruction. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Cruciate Ligament Rupture
• Intervention / Treatment: Device: Arthroscopic surgical robot; Device: Conventional arthroscopic cruciate ligament reconstruction

Detailed Description

In this study, 30 patients with the first rupture of the cruciate ligament were recruited as the research objects, and the ratio of the experimental group and the control group was 1:1. Patients in the experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction, and patients in the control group will be treated with conventional reconstruction. All subjects will undergo CT evaluation and clinical function evaluation. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingfang Ao, Prof.; Phone Number: 18811332558; Email: aoyingfang@163.com
• Study Contact Backup: Name: Xin Zhang, Ph.D.; Phone Number: 18811332558; Email: caochenxi116@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18-45 years old, with closed epiphyses;
2. For the first time, the knee joint is simply ruptured with a cruciate ligament and requires surgical reconstruction; it can be combined with meniscus injury, and the Outerbridge injury score is ≤ II;
3. There is no history of trauma or fracture of the ipsilateral knee joint;
4. The medial collateral ligament or the lateral collateral ligament is not damaged or only slightly damaged (no more than degree I).

Exclusion Criteria:

1. BMI is less than 18.5 or greater than 35 kg/m2;
2. Patients with moderate or severe knee degeneration;
3. Those with limited flexion angle (<120 degrees);
4. Cartilage defect area is greater than 2 cm2 or Outerbridge damage score> Grade II.

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: Arthroscopic surgical robot assisted navigation and positioning for cruciate ligament reconstruction; Patient undergoes cruciate ligament reconstruction with robot-assisted navigation and positioning under arthroscopic surgery	Device: Arthroscopic surgical robot; The surgeon performs cruciate ligament bone canal positioning and ligament reconstruction with the assistance of an arthroscopic surgical robot
Active Comparator: Conventional arthroscopic cruciate ligament reconstruction; The patient undergoes conventional arthroscopic cruciate ligament reconstruction	Device: Conventional arthroscopic cruciate ligament reconstruction; The surgeon performs conventional arthroscopic cruciate ligament reconstruction surgery without other auxiliary equipment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D-CT compares the position of the tibial canal made by the robot-assisted positioning and the traditional positioning method	Evaluate the position of the reconstructed tibia canal through 3D-CT using Taukada's method, t / T × 100% was used to evaluate the anteroposterior radial orientation of the tibial tract. Use l / L × 100% to evaluate the orientation of the inner and outer diameters of the tibial tract.	Knee CT examinations were performed on patients one week after surgery
3D-CT compares the position of the femoral canal made by the robot-assisted positioning and the traditional positioning method	Evaluate the position of the reconstructed femoral canal through 3D-CT according to Bernard and Hertel (BH) quadrant method, l / L × 100% and h / H × 100% are used to evaluate the femoral bone canal positioning.	Knee CT examinations were performed on patients one week after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Yingfang Ao, Prof., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: M2021156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No