Technology and System for Minimally Invasive TKA Surgery Robot

July 1, 2021 updated by: Peking University Third Hospital
Developed a robot for minimally invasive TKA surgery and prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic surgery group
Procedure: Robotic TKA
Robotic TKA
Active Comparator: Manual operation group
Procedure: Manual operation
Manual operation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2021188

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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