Technology and System for Minimally Invasive TKA Surgery Robot

Sponsor
Peking University Third Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04953988
Collaborator
(none)
10
2
25

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Robotic TKA
  • Procedure: Manual operation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Technology and System for Minimally Invasive TKA Surgery Robot
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Robotic surgery group

Procedure: Robotic TKA
Robotic TKA

Active Comparator: Manual operation group

Procedure: Manual operation
Manual operation

Outcome Measures

Primary Outcome Measures

  1. Full-length radiography of both lower limbs [Before and two days after the operation]

    Measurement of lower limb force line and prosthesis position through full-length radiography of both lower limbs

  2. Conventional anteroposterior radiograph of Both Lower Extremities [Before and two days after the operation]

    Measurement of lower limb force line and prosthesis position through conventional anteroposterior radiograph of Both Lower Extremities

  3. computed tomography [Before and two days after the operation]

    Measurement of lower limb force line and prosthesis position through computed tomography

  4. Magnetic Resonance Imaging [Before and two days after the operation]

    Measurement of lower limb force line and prosthesis position through Magnetic Resonance Imaging

  5. Range of motion [Before and two days after the operation]

    Knee joint range of motion. Normal flexion 150°, extension 0°

  6. Operation time [During the operation]

    The time from the start of the skin incision to the completion of the skin suture

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04953988
Other Study ID Numbers:
  • M2021188
First Posted:
Jul 8, 2021
Last Update Posted:
Jul 8, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2021