Clinical trial NCT04980183: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cruciate Ligament Rupture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 3D-CT compares the position of the tibial canal made by the robot-assisted positioning and the traditional positioning method
timeFrame: Knee CT examinations were performed on patients one week after surgery
measure: 3D-CT compares the position of the femoral canal made by the robot-assisted positioning and the traditional positioning method
timeFrame: Knee CT examinations were performed on patients one week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yingfang Ao, Prof.
role: PRINCIPAL_INVESTIGATOR
References: