search
Back to results

Technology and System for Minimally Invasive TKA Surgery Robot

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Robotic TKA
Manual operation
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring KOA, TKA, robotic surgery

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Robotic surgery group

    Manual operation group

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2021
    Last Updated
    July 1, 2021
    Sponsor
    Peking University Third Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04953988
    Brief Title
    Technology and System for Minimally Invasive TKA Surgery Robot
    Official Title
    Technology and System for Minimally Invasive TKA Surgery Robot
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2021 (Anticipated)
    Primary Completion Date
    July 1, 2021 (Anticipated)
    Study Completion Date
    August 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee
    Keywords
    KOA, TKA, robotic surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Robotic surgery group
    Arm Type
    Experimental
    Arm Title
    Manual operation group
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Robotic TKA
    Intervention Description
    Robotic TKA
    Intervention Type
    Procedure
    Intervention Name(s)
    Manual operation
    Intervention Description
    Manual operation
    Primary Outcome Measure Information:
    Title
    Full-length radiography of both lower limbs
    Description
    Measurement of lower limb force line and prosthesis position through full-length radiography of both lower limbs
    Time Frame
    Before and two days after the operation
    Title
    Conventional anteroposterior radiograph of Both Lower Extremities
    Description
    Measurement of lower limb force line and prosthesis position through conventional anteroposterior radiograph of Both Lower Extremities
    Time Frame
    Before and two days after the operation
    Title
    computed tomography
    Description
    Measurement of lower limb force line and prosthesis position through computed tomography
    Time Frame
    Before and two days after the operation
    Title
    Magnetic Resonance Imaging
    Description
    Measurement of lower limb force line and prosthesis position through Magnetic Resonance Imaging
    Time Frame
    Before and two days after the operation
    Title
    Range of motion
    Description
    Knee joint range of motion. Normal flexion 150°, extension 0°
    Time Frame
    Before and two days after the operation
    Title
    Operation time
    Description
    The time from the start of the skin incision to the completion of the skin suture
    Time Frame
    During the operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Technology and System for Minimally Invasive TKA Surgery Robot

    We'll reach out to this number within 24 hrs