Technology and System for Minimally Invasive TKA Surgery Robot

Peking University

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Procedure: Robotic TKA; Procedure: Manual operation

Study type: Interventional

Funder types: Other

Identifiers

NCT04953988

M2021188

Details and patient eligibility

About

Developed a robot for minimally invasive TKA surgery and prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.

Full description

1. For the current minimally invasive total knee arthroplasty, due to the limitation of the surgical field of view and the scope of operation, and the error of the intraoperative osteotomy saw, it can cause intraoperative damage to ligaments, nerves and blood vessels, postoperative lower limb force lines and prosthesis position Poor, abnormal movement and force of the patellofemoral joint and tibiofemoral joint after surgery can easily lead to clinical symptoms such as rapid wear of the prosthesis, short service life, postoperative knee pain, and even possible problems with surgical failure and revision. Developed a robot for minimally invasive total knee replacement surgery. Minimally invasive total knee arthroplasty is performed by surgical robot and manual operation. According to intraoperative and postoperative imaging observations, the position of the prosthesis, and the evaluation of soft tissue balance during and after the operation, the two methods are compared with the surgical robot and manual operation. Kind of surgery.
2. To prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.

Enrollment: 10 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. No surgery on the knee joint.
2. Age>55

Exclusion criteria

1. Knee surgery history.
2. Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability.
3. Severe flexion contracture deformity.
4. Revision and replacement surgery for knee joints.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Robotic surgery group

Experimental group

Treatment:

Procedure: Robotic TKA

Manual operation group

Active Comparator group

Treatment:

Procedure: Manual operation