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Technology and System for Minimally Invasive TKA Surgery Robot

Technology and System for Minimally Invasive TKA Surgery Robot

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04953988
Enrollment
10
Registered
2021-07-08
Start date
2021-07-01
Completion date
2023-08-01
Last updated
2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

KOA, TKA, robotic surgery

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

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.

Interventions

PROCEDURERobotic TKA

Robotic TKA

PROCEDUREManual operation

Manual operation

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Full-length radiography of both lower limbsBefore and two days after the operationMeasurement of lower limb force line and prosthesis position through full-length radiography of both lower limbs
Conventional anteroposterior radiograph of Both Lower ExtremitiesBefore and two days after the operationMeasurement of lower limb force line and prosthesis position through conventional anteroposterior radiograph of Both Lower Extremities
computed tomographyBefore and two days after the operationMeasurement of lower limb force line and prosthesis position through computed tomography
Magnetic Resonance ImagingBefore and two days after the operationMeasurement of lower limb force line and prosthesis position through Magnetic Resonance Imaging
Range of motionBefore and two days after the operationKnee joint range of motion. Normal flexion 150°, extension 0°
Operation timeDuring the operationThe time from the start of the skin incision to the completion of the skin suture

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026