Technology and System for Minimally Invasive TKA Surgery Robot

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Manual operation; Procedure: Robotic TKA

• Registration Number: NCT04953988
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-24
• Study Start: 2021-07-01
• Primary Completion: 2021-07-01
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual operation group	Manual operation	-
Robotic surgery group	Robotic TKA	-

Primary Outcome Measures

Name	Time	Method
Full-length radiography of both lower limbs	Before and two days after the operation	Measurement of lower limb force line and prosthesis position through full-length radiography of both lower limbs
Conventional anteroposterior radiograph of Both Lower Extremities	Before and two days after the operation	Measurement of lower limb force line and prosthesis position through conventional anteroposterior radiograph of Both Lower Extremities
Operation time	During the operation	The time from the start of the skin incision to the completion of the skin suture
computed tomography	Before and two days after the operation	Measurement of lower limb force line and prosthesis position through computed tomography
Magnetic Resonance Imaging	Before and two days after the operation	Measurement of lower limb force line and prosthesis position through Magnetic Resonance Imaging
Range of motion	Before and two days after the operation	Knee joint range of motion. Normal flexion 150°, extension 0°