Back to resultsA Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments
Primary Purpose
Cruciate Ligament Rupture
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Arthroscopic surgical robot
Conventional arthroscopic cruciate ligament reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Cruciate Ligament Rupture
Eligibility Criteria
Inclusion Criteria:
- 18-45 years old, with closed epiphyses;
- 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;
- There is no history of trauma or fracture of the ipsilateral knee joint;
- The medial collateral ligament or the lateral collateral ligament is not damaged or only slightly damaged (no more than degree I).
Exclusion Criteria:
- BMI is less than 18.5 or greater than 35 kg/m2;
- Patients with moderate or severe knee degeneration;
- Those with limited flexion angle (<120 degrees);
- Cartilage defect area is greater than 2 cm2 or Outerbridge damage score> Grade II.
Sites / Locations
- Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arthroscopic surgical robot assisted navigation and positioning for cruciate ligament reconstruction
Conventional arthroscopic cruciate ligament reconstruction
Arm Description
Patient undergoes cruciate ligament reconstruction with robot-assisted navigation and positioning under arthroscopic surgery
The patient undergoes conventional arthroscopic cruciate ligament reconstruction
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04980183
First Posted
June 25, 2021
Last Updated
July 18, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04980183
Brief Title
A Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments
Official Title
A Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cruciate Ligament Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic surgical robot assisted navigation and positioning for cruciate ligament reconstruction
Arm Type
Experimental
Arm Description
Patient undergoes cruciate ligament reconstruction with robot-assisted navigation and positioning under arthroscopic surgery
Arm Title
Conventional arthroscopic cruciate ligament reconstruction
Arm Type
Active Comparator
Arm Description
The patient undergoes conventional arthroscopic cruciate ligament reconstruction
Intervention Type
Device
Intervention Name(s)
Arthroscopic surgical robot
Intervention Description
The surgeon performs cruciate ligament bone canal positioning and ligament reconstruction with the assistance of an arthroscopic surgical robot
Intervention Type
Device
Intervention Name(s)
Conventional arthroscopic cruciate ligament reconstruction
Intervention Description
The surgeon performs conventional arthroscopic cruciate ligament reconstruction surgery without other auxiliary equipment
Primary Outcome Measure Information:
Title
3D-CT compares the position of the tibial canal made by the robot-assisted positioning and the traditional positioning method
Description
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.
Time Frame
Knee CT examinations were performed on patients one week after surgery
Title
3D-CT compares the position of the femoral canal made by the robot-assisted positioning and the traditional positioning method
Description
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.
Time Frame
Knee CT examinations were performed on patients one week after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-45 years old, with closed epiphyses;
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;
There is no history of trauma or fracture of the ipsilateral knee joint;
The medial collateral ligament or the lateral collateral ligament is not damaged or only slightly damaged (no more than degree I).
Exclusion Criteria:
BMI is less than 18.5 or greater than 35 kg/m2;
Patients with moderate or severe knee degeneration;
Those with limited flexion angle (<120 degrees);
Cartilage defect area is greater than 2 cm2 or Outerbridge damage score> Grade II.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Zhang, Ph.D.
Phone
18811332558
Email
caochenxi116@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yingfang Ao, Prof.
Phone
18811332558
Email
aoyingfang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingfang Ao, Prof.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments
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