NCT06010979

Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12,000 (estimated)
• Sponsor: Tian Hua · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-08-25
• Last updated: 2023-08-25

Locations

1 site across 1 country: China