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

Peking University

Status: Unknown

Conditions: Cruciate Ligament Rupture

Treatments: Device: Conventional arthroscopic cruciate ligament reconstruction; Device: Arthroscopic surgical robot

Study type: Interventional

Funder types: Other

Identifiers

NCT04980183

M2021156

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Arthroscopic surgical robot assisted navigation and positioning for cruciate ligament reconstruction

Experimental group

Description:

Patient undergoes cruciate ligament reconstruction with robot-assisted navigation and positioning under arthroscopic surgery

Treatment:

Device: Arthroscopic surgical robot

Conventional arthroscopic cruciate ligament reconstruction

Active Comparator group

Description:

The patient undergoes conventional arthroscopic cruciate ligament reconstruction

Treatment:

Device: Conventional arthroscopic cruciate ligament reconstruction