Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

NCT ID: NCT06010979

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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conventional group

Conventional instrument-assisted knee arthroplasty

conventional intrumentation assisted knee arthroplasty

Intervention Type PROCEDURE

conventional intrumentation assisted knee arthroplasty

CAS group

computer navigation assisted knee arthroplasty

computer navigation assisted knee arthroplasty

Intervention Type PROCEDURE

computer navigation assisted knee arthroplasty

RAS group

robotic system assisted knee arthroplasty

robotic system assisted knee arthroplasty

Intervention Type PROCEDURE

robotic system assisted knee arthroplasty

PSI group

patient-spercific instrumentation assisted knee arthroplasty

patient-spercific assisted knee arthroplasty

Intervention Type PROCEDURE

patient-spercific assisted knee arthroplasty

Interventions

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conventional intrumentation assisted knee arthroplasty

conventional intrumentation assisted knee arthroplasty

Intervention Type PROCEDURE

computer navigation assisted knee arthroplasty

computer navigation assisted knee arthroplasty

Intervention Type PROCEDURE

robotic system assisted knee arthroplasty

robotic system assisted knee arthroplasty

Intervention Type PROCEDURE

patient-spercific assisted knee arthroplasty

patient-spercific assisted knee arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tian Hua

OTHER

Sponsor Role lead

Responsible Party

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Tian Hua

archiater

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tian Hua, MD

Role: STUDY_DIRECTOR

Director

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tian Hua, MD

Role: CONTACT

86-13511065187

Zheng Yuhang, MD

Role: CONTACT

86-18811185091

Facility Contacts

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Tian Hua, MD

Role: primary

86-18211070116

Zheng Yuhang, bachelor

Role: backup

86-18811185091

Other Identifiers

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TKAcohort

Identifier Type: -

Identifier Source: org_study_id

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