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

Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04980183
• Other study ID #: M2021156
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: Xin Zhang, Ph.D.
• Phone: 18811332558
• Email: caochenxi116[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cruciate Ligament Rupture
• Rupture

Intervention

Device:
• Arthroscopic surgical robot
The surgeon performs cruciate ligament bone canal positioning and ligament reconstruction with the assistance of an arthroscopic surgical robot
• Conventional arthroscopic cruciate ligament reconstruction
The surgeon performs conventional arthroscopic cruciate ligament reconstruction surgery without other auxiliary equipment

Locations

Country	Name	City	State
China	Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries, Beijing, China	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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