A Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2021
CompletedFirst Posted
Study publicly available on registry
July 28, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedJuly 28, 2021
July 1, 2021
9 months
June 25, 2021
July 18, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Arthroscopic surgical robot assisted navigation and positioning for cruciate ligament reconstruction
EXPERIMENTALPatient undergoes cruciate ligament reconstruction with robot-assisted navigation and positioning under arthroscopic surgery
Conventional arthroscopic cruciate ligament reconstruction
ACTIVE COMPARATORThe patient undergoes conventional arthroscopic cruciate ligament reconstruction
Interventions
The surgeon performs cruciate ligament bone canal positioning and ligament reconstruction with the assistance of an arthroscopic surgical robot
The surgeon performs conventional arthroscopic cruciate ligament reconstruction surgery without other auxiliary equipment
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
Beijing, Beijing Municipality, 100191, China
Study Officials
- PRINCIPAL INVESTIGATOR
Yingfang Ao, Prof.
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2021
First Posted
July 28, 2021
Study Start
August 1, 2021
Primary Completion
May 1, 2022
Study Completion
May 1, 2024
Last Updated
July 28, 2021
Record last verified: 2021-07