Technology and System for Minimally Invasive TKA Surgery Robot

Study Overview
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Brief Summary
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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
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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. To prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.

Official Title
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Technology and System for Minimally Invasive TKA Surgery Robot

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Robotic TKA
* Procedure: Manual operation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No surgery on the knee joint. Age>55 Exclusion Criteria: Knee surgery history. Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability. Severe flexion contracture deformity. Revision and replacement surgery for knee joints.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic surgery group<br> | Procedure: Robotic TKA<br>* Robotic TKA<br>|
| Active Comparator: Manual operation group<br> | Procedure: Manual operation<br>* Manual operation<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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KOA, TKA, robotic surgery