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3D Printing Guides in Total Knee Arthroplasty

NCT ID: NCT04206202

Last Updated: 2019-12-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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PSI group

3D-printed patient-specific instrumentation (PSI) will be used in the total knee arthroplasty (TKA) of this group.

Group Type EXPERIMENTAL

3D-Printed Patient-Specific Intramedullary Guide

Intervention Type DEVICE

The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.

Interventions

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3D-Printed Patient-Specific Intramedullary Guide

The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced OA of the knee, varus deformity of no more than 15 degrees, flexion-contracture deformity of no more than 10 degrees, without extra-articular deformity of the knee;
* Weight-bearing radiograph of the X-ray image showed the OA Kellgren-Lawrence classification grade Ⅳ;
* The treatment for the patient was TKA, whether or not to use PSI depends on the actual grouping.

Exclusion Criteria

* Patients with varus deformity of more than 15 degrees, flexion-contracture deformity of more than 10 degrees of the knee;
* Patients with traumatic arthritis and inflammatory arthritis;
* Patients with huge bone defects around the knee
* Patients who had active infection around the knee;
* Patients with knee valgus deformity;
* Patients with severe extra-articular deformity;
* Patients who had previous knee surgery;
* Patients who had periarticular soft tissue dysfunction and neuropathy;
* Patients who had poor physical condition and could not withstand the operation;
* Patients who refused to be followed.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Xiaojun Duan

Deputy Director of the Center for Joint Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rui He, M.D.

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, China

Locations

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Southwest Hospital

Chongqing, , China

Site Status

Countries

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China

Other Identifiers

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3DKneeGuide

Identifier Type: -

Identifier Source: org_study_id