Technology and System for Minimally Invasive TKA Surgery Robot

Osteoarthritis, Knee Clinical Trial

Official title:

Technology and System for Minimally Invasive TKA Surgery Robot

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04953988
• Other study ID #: M2021188
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• Robotic TKA
Robotic TKA
• Manual operation
Manual operation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full-length radiography of both lower limbs	Measurement of lower limb force line and prosthesis position through full-length radiography of both lower limbs	Before and two days after the operation
Primary	Conventional anteroposterior radiograph of Both Lower Extremities	Measurement of lower limb force line and prosthesis position through conventional anteroposterior radiograph of Both Lower Extremities	Before and two days after the operation
Primary	computed tomography	Measurement of lower limb force line and prosthesis position through computed tomography	Before and two days after the operation
Primary	Magnetic Resonance Imaging	Measurement of lower limb force line and prosthesis position through Magnetic Resonance Imaging	Before and two days after the operation
Primary	Range of motion	Knee joint range of motion. Normal flexion 150°, extension 0°	Before and two days after the operation
Primary	Operation time	The time from the start of the skin incision to the completion of the skin suture	During the operation