Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: conventional intrumentation assisted knee arthroplasty, computer navigation assisted knee arthroplasty, robotic system assisted knee arthroplasty, patient-spercific assisted knee arthroplasty.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure conventional intrumentation assisted knee arthroplasty
conventional intrumentation assisted knee arthroplasty - Procedure computer navigation assisted knee arthroplasty
computer navigation assisted knee arthroplasty - Procedure robotic system assisted knee arthroplasty
robotic system assisted knee arthroplasty - Procedure patient-spercific assisted knee arthroplasty
patient-spercific assisted knee arthroplasty
Primary outcome measures
- mechanical axis [Time frame: Postoperative day 3]
Secondary outcome measures (12)
- operation time [Time frame: immediately after the surgery]
- Intraoperative blood loss [Time frame: immediately after the surgery]
- Intraoperative complications [Time frame: immediately after the surgery]
- Total postoperative blood loss [Time frame: Postoperative day 3]
- Blood transfusion rate [Time frame: At discharge]
- Postoperative complication [Time frame: 3 years postoperatively]
- Rotation Angle of femur prosthesis [Time frame: Postoperative day 3]
- Visual analogue scale [Time frame: Postoperative day 3]
- Visual analogue scale [Time frame: 2 weeks postoperatively]
- Visual analogue scale [Time frame: 6 weeks postoperatively]
- Visual analogue scale [Time frame: 3 months postoperatively]
- Visual analogue scale [Time frame: 6 months postoperatively]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT06010979 · TKAcohort