Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

Tian Hua

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Procedure: patient-spercific assisted knee arthroplasty; Procedure: robotic system assisted knee arthroplasty; Procedure: computer navigation assisted knee arthroplasty; Procedure: conventional intrumentation assisted knee arthroplasty

Study type: Observational

Funder types: Other

Identifiers

NCT06010979

TKAcohort

Details and patient eligibility

About

Through this cohort study, previous clinical data can be systematically reviewed and supplemented through clinical follow-up. Prospective enrollment and follow-up observation of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The intraoperative, perioperative, clinical follow-up and health economics of surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA were comprehensively and objectively compared, the results and conclusions of the center were summarized and reported, and the effectiveness and safety of digital assistive technology applied to TKA were explored, providing references for clinical diagnosis and follow-up research.

Full description

Through this cohort study, previous clinical data can be systematically reviewed and supplemented by follow-up visits. Prospective enrollment and follow-up of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The preoperative situation (general statistical information, educational level, preoperative clinical function score, etc.), intraoperative situation (operative time, intraoperative blood loss, intraoperative complications, etc.), perioperative situation (total postoperative blood loss, blood transfusion rate, postoperative complications, etc.) and clinical follow-up situation were comprehensively and objectively compared with surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA We summarized and reported the results and conclusions of the center (postoperative force line, implant location, pain, mobility, clinical function score, patient satisfaction and postoperative complications, etc.) and health economics (average length of stay, hospitalization cost, etc.) to provide reference for clinical diagnosis and follow-up research.

Enrollment: 12,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• a. primary knee osteoarthritis;
• b. Unilateral primary knee replacement;
• c. Surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide

Exclusion criteria

• a. A history of renal insufficiency (Cr > 2.5), liver insufficiency, severe heart disease (or coronary stenting within the last 12 months), severe respiratory disease, history of VTE or high risk of thrombosis (hereditary/acquired thrombotic disease), cotting disorder, stroke, and malignancy;
• b. Those who do not accept this test for any reason and refuse to sign the informed consent.

Trial design

12,000 participants in 4 patient groups

conventional group

Description:

Conventional instrument-assisted knee arthroplasty

Treatment:

Procedure: conventional intrumentation assisted knee arthroplasty

CAS group

Description:

computer navigation assisted knee arthroplasty

Treatment:

Procedure: computer navigation assisted knee arthroplasty

RAS group

Description:

robotic system assisted knee arthroplasty

Treatment:

Procedure: robotic system assisted knee arthroplasty

PSI group

Description:

patient-spercific instrumentation assisted knee arthroplasty

Treatment:

Procedure: patient-spercific assisted knee arthroplasty