Application of Knee Measurements on 3D CT in TKR

NCT ID: NCT06475014

Last Updated: 2024-06-26

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

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-25

Study Completion Date

2023-12-01

Brief Summary

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A 3D Computed Tomographic Study of Vietnamese Knee Morphology for Total knee Replacement

Detailed Description

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There were controversies and inconsistent results regarding the effectiveness of PSI.

However, most authors used PSI from commercial manufacturers. From our view, the surgeon's involvement in PSI planning and design can affect the PSI's accuracy. Some other benefits of in-hospital PSI included the use of any type of implant without depending on the manufacturer's software system, faster and cheaper. Therefore, we conducted this study to evaluate the effect of in-hospital PSI in which the surgeons take part in the manufacturing job.

Conditions

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Knee Osteoarthritis Knee Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Knee with OA

Underwent Total Knee replacement Surgery, using 3D printed PSI,

Total knee replacement

Intervention Type PROCEDURE

Mechanical Alignment Using PSI Pre and post-operative CT Scan

Interventions

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Total knee replacement

Mechanical Alignment Using PSI Pre and post-operative CT Scan

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of knee osteoarthritis, grade III, IV
* Underwent total knee replacement using patient-specific intrumentation
* With pre and post-operative whole limb CT-Scanners

Exclusion Criteria

* Paticipants with valgus knee deformity,
* A history of hip arthroplasty,
* Large bone defect that required augments.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vinmec Healthcare System

OTHER

Sponsor Role lead

Responsible Party

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Vo Sy Quyen Nang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duong Dinh Toan, Ph.D

Role: STUDY_CHAIR

Hanoi Medical University

Locations

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Vinmec Times City Hospital

Hanoi, Hai Ba Trung, Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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VOSCknee3D

Identifier Type: -

Identifier Source: org_study_id

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