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
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring KOA, TKA, robotic surgery
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.
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
NCT ID
NCT04953988
First Posted
June 24, 2021
Last Updated
July 1, 2021
Sponsor
Peking University Third Hospital
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
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