Viewing Study NCT04206202


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Study NCT ID: NCT04206202
Status: UNKNOWN
Last Update Posted: 2019-12-20
First Post: 2019-12-15
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: 3D Printing Guides in Total Knee Arthroplasty
Sponsor: Southwest Hospital, China
Organization:

Study Overview

Official Title: Application of 3D Printing Patient-specific Instrumentation in Total Knee Arthroplasty
Status: UNKNOWN
Status Verified Date: 2019-12
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study aims to design a patient-specific instrumentation to be used in total knee arthroplasty and evaluate its accuracy of femoral component rotation and intramedullary guide so as to explore its clinical effects.
Detailed Description: Total knee arthroplasty (TKA) is the most universal and effective means for treating terminal stage osteoarthritis (OA) of knee. With the development of three-dimensional printing (3DP) technology in the medical domain, the application of patient-specific instrumentation (PSI) in arthroplasty has become more common. The aim of this study was to design a PSI to achieve appropriate femoral resection and accurate component rotation for a successful TKA, and to explore its clinical effects.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: