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A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty

NCT ID: NCT04181528

Last Updated: 2019-11-29

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

2019-12-01

Study Completion Date

2022-12-31

Brief Summary

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Total knee arthroplasty(TKA) is a successful orthopedic surgery with excellent clinical outcome and survival. However, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(PROMs) of some studies. Therefore, for improving the patient's outcome and satisfaction after total knee arthroplasty, it is necessary to change the design of the conventional total knee arthroplsaty implant. The knee is a joint structure with several dynamic functions, and not only the skeletal structure but also the soft tissue balance plays an important role in the function of the knee joint. New implants are being developed to overcome the limitations of conventional TKA implant, including the Journey II Bi-cruciate substituting total knee system (JII-BCS; Smith \& Nephew). JII-BCS implant has normal articular geometry, more anatomical femoral shape, lateral tibial convex geometry, and asymmetrical tibial plateau, anterior and posterior cams, which has been shown in experimental studies to produce nearly normal knee movement by reproducing the actual normal anatomical alignment in vivo. The clinical results of the kinematic effects of this anatomcally aligned change are insufficient, and there is also a lack of comparative studies with conventional total knee arthroplasty implant. The purpose of this study is to compare outcomes between anatomically aligned TKA(JII-BCS) and conventional TKA(Legion total knee system, Smith \& Nephew). This study is a randomized controlled study in patients undergoing unilateral total knee arthroplasty. A patient will undergo unilateral TKA with anatomically aligned or conventional TKA implant. The implant is determined using a random number table. Radiologic parameter, patients preference and clinical results was investigated in patients who received unilateral TKA during minimum 2 year follow up.

Detailed Description

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Conditions

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Knee Osteoarthritis Anatomically Aligned Total Knee Arthroplasty

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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Anatomically aligned total knee arthroplasty

Use anatomically aligned TKA implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith \& Nephew) in patients undergoing unilateral TKA

Group Type EXPERIMENTAL

Total knee arthroplasty implant

Intervention Type DEVICE

In patients undergoing unilateral TKA, decide the implant of TKA (anatomically aligned or conventional TKA implant) will be decided using ramdon number table

Conventaional total knee arthroplasty

Use conventional TKA implant (Legion total knee system, JII-BCS, Smith \& Nephew) in patients undergoing unilateral TKA

Group Type ACTIVE_COMPARATOR

Total knee arthroplasty implant

Intervention Type DEVICE

In patients undergoing unilateral TKA, decide the implant of TKA (anatomically aligned or conventional TKA implant) will be decided using ramdon number table

Interventions

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Total knee arthroplasty implant

In patients undergoing unilateral TKA, decide the implant of TKA (anatomically aligned or conventional TKA implant) will be decided using ramdon number table

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients for bilateral total knee arthroplasty
* having medicare insurance

Exclusion Criteria

* Rheumatoid arthritis
* Other inflammatory arthritis
* Crystal-induced arthritis
* Septic arthritis
* Neuropsychiatric patients
* Previous knee operation history
* Neuropsychiatric patients
* Patients with preoperative severe limitation of motion (Flexion contracture ≥ 20, range of motion ≤ 90)
* Patients with preoperative severe defomity of knee alignment (Varus or valgus angle ≥ 15)
* Severe obese patients (BMI ≥ 40)
Minimum Eligible Age

19 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, MD, PhD

Role: STUDY_CHAIR

the Catholic Univerisity of Korea Seoul St Mary's hospital

Central Contacts

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Yong In, MD, PhD

Role: CONTACT

Phone: 821090445228

Email: [email protected]

Mansoo Mansoo, MD, PhD

Role: CONTACT

Phone: 821072333875

Email: [email protected]

Other Identifiers

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Anatomically aligned TKRA3

Identifier Type: -

Identifier Source: org_study_id