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Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses

NCT ID: NCT04684160

Last Updated: 2020-12-24

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-19

Study Completion Date

2022-12-31

Brief Summary

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Comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with Titanium-nitride.

Detailed Description

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Despite numerous comparison studies between mobile- and fixed-bearing TKA as well as several comparison studies regarding clinical and radiological outcomes using titanium-nitride(TiN) prosthesis, there has been no study on postoperative joint awareness despite mobile- and fixed-bearing TKA using TiN prosthesis.

Conditions

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Osteoarthritis, Knee Arthropathy of Knee Joint Awareness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fixed-bearing group

Group Type ACTIVE_COMPARATOR

Fixed-bearing TKA

Intervention Type DEVICE

Mobile-bearing group

Group Type EXPERIMENTAL

Mobile-bearing TKA

Intervention Type DEVICE

Interventions

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Fixed-bearing TKA

Intervention Type DEVICE

Mobile-bearing TKA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with knee joint advanced osteoarthritis
* Age over 55 years old
* Scheduled to undergo primary total knee arthroplasty

Exclusion Criteria

* Post-traumatic or inflammatory osteoarthritis
* Those who undertook previous ligamentous surgery
* Those who do not understand and give answers to a survey
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Yong In

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong In, M.D., Ph.D.

Role: STUDY_CHAIR

Seoul St. Mary's Hospital

Locations

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The Catholic University of Korea Seoul St Mary's hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CUKorea MB

Identifier Type: -

Identifier Source: org_study_id