Technology and System for Minimally Invasive TKA Surgery Robot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-08-01

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.

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Detailed Description

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic surgery group

Group Type EXPERIMENTAL

Robotic TKA

Intervention Type PROCEDURE

Robotic TKA

Manual operation group

Group Type ACTIVE_COMPARATOR

Manual operation

Intervention Type PROCEDURE

Manual operation

Interventions

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Robotic TKA

Intervention Type PROCEDURE

Manual operation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes