Clinical trial NCT06010979: Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
Official title: Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Keywords: total knee arthroplasty
knee osteoarthritis
computer navigation
robotic system
patient-spercific instrumentation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing knee replacement in our hospital

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: mechanical axis
timeFrame: Postoperative day 3
Secondary outcomes:
measure: operation time
timeFrame: immediately after the surgery
measure: Intraoperative blood loss
timeFrame: immediately after the surgery
measure: Intraoperative complications
timeFrame: immediately after the surgery
measure: Total postoperative blood loss
timeFrame: Postoperative day 3
measure: Blood transfusion rate
timeFrame: At discharge
measure: Postoperative complication
timeFrame: 3 years postoperatively
measure: Rotation Angle of femur prosthesis
timeFrame: Postoperative day 3
measure: Visual analogue scale
timeFrame: Postoperative day 3
measure: Visual analogue scale
timeFrame: 2 weeks postoperatively
measure: Visual analogue scale
timeFrame: 6 weeks postoperatively
measure: Visual analogue scale
timeFrame: 3 months postoperatively
measure: Visual analogue scale
timeFrame: 6 months postoperatively
measure: Visual analogue scale
timeFrame: 12 months postoperatively
measure: Visual analogue scale
timeFrame: 24 months postoperatively
measure: Visual analogue scale
timeFrame: 36 months postoperatively
measure: Range of motion
timeFrame: 3 days postoperatively
measure: Range of motion
timeFrame: 2 weeks postoperatively
measure: Range of motion
timeFrame: 6 weeks postoperatively
measure: Range of motion
timeFrame: 3 months postoperatively
measure: Range of motion
timeFrame: 6 months postoperatively
measure: Range of motion
timeFrame: 12 months postoperatively
measure: Range of motion
timeFrame: 24 months postoperatively
measure: Range of motion
timeFrame: 36 months postoperatively
measure: knee society score
timeFrame: 6 weeks postoperatively
measure: knee society score
timeFrame: 3 months postoperatively
measure: knee society score
timeFrame: 6 months postoperatively
measure: knee society score
timeFrame: 12 months postoperatively
measure: knee society score
timeFrame: 24 months postoperatively
measure: knee society score
timeFrame: 36 months postoperatively
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 6 weeks postoperatively
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 3 months postoperatively
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 6 months postoperatively
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 12 months postoperatively
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 24 months postoperatively
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 36 months postoperatively
measure: Patient satisfaction
timeFrame: 6 months postoperatively
measure: Patient satisfaction
timeFrame: 12 months postoperatively
measure: Patient satisfaction
timeFrame: 24 months postoperatively
measure: Patient satisfaction
timeFrame: 36 months postoperatively
measure: Length of stay
timeFrame: an average of 3 days postoperatively
measure: Medical expenses
timeFrame: an average of 3 days postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Director
name: Tian Hua, MD
role: STUDY_DIRECTOR
References: