Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Tian Hua
- Enrollment
- 12000
- Locations
- 1
- Primary Endpoint
- mechanical axis
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Tian Hua
archiater
Peking University Third Hospital
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.
Outcomes
Primary Outcomes
mechanical axis
Time Frame: Postoperative day 3
The postoperative HKA Angle was measured, that is, the Angle between the center of the hip joint and the center of the knee joint and the center of the knee joint and the center of the ankle joint on the full-length X-ray film of the lower limb. The target Angle was defined as 0°, the Angle was positive when the knee was varus, the Angle was negative when the knee was varus, and the acceptable range was ±3°, beyond which the line deviation was defined.
Secondary Outcomes
- operation time(immediately after the surgery)
- Postoperative complication(3 years postoperatively)
- Intraoperative blood loss(immediately after the surgery)
- Intraoperative complications(immediately after the surgery)
- Total postoperative blood loss(Postoperative day 3)
- Western Ontario and McMaster Universities Osteoarthritis Index(36 months postoperatively)
- Blood transfusion rate(At discharge)
- Rotation Angle of femur prosthesis(Postoperative day 3)
- Visual analogue scale(36 months postoperatively)
- Range of motion(36 months postoperatively)
- knee society score(36 months postoperatively)
- Patient satisfaction(36 months postoperatively)
- Length of stay(an average of 3 days postoperatively)
- Medical expenses(an average of 3 days postoperatively)