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Comparison of Anatomically Aligned and Conventional Total Knee Arthroplasty in the Same Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04181216
Recruitment Status : Not yet recruiting
First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yong In, The Catholic University of Korea

Brief Summary:

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 total knee arthroplasty per day. Radiologic parameter, patients preference and clinical results was investigated in both knee of same patients who received TKA during minimum 2 year follow up.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Anatomically Aligned Total Knee Arthroplasty Device: Anatomically aligned total knee arthroplasty implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Anatomically Aligned and Conventional Total Knee Arthroplasty in the Same Patients
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: anatomically aligned total knee arthroplasty prosthesis
Total knee arthroplasty with anatomically aligned total knee arthroplasty implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith & Nephew)
Device: Anatomically aligned total knee arthroplasty implant
In same patient, one total knee arthroplasty using anatomically aligned total knee arthroplasty implant Other total knee arthroplasty using conventional total knee arthroplasty implant

Active Comparator: Conventaional total knee arthroplasty group
Total knee arthroplasty with conventional total knee arthroplasty implant (Legion total knee system, Smith & Nephew)
Device: Anatomically aligned total knee arthroplasty implant
In same patient, one total knee arthroplasty using anatomically aligned total knee arthroplasty implant Other total knee arthroplasty using conventional total knee arthroplasty implant




Primary Outcome Measures :
  1. Change in Western Ontario and McMaster Universities Index(WOMAC index) [ Time Frame: Change from baseline score to score of postoperative1 year ]

Secondary Outcome Measures :
  1. Change in Knee Society Score [ Time Frame: Change from baseline score to score of postoperative1 year ]
  2. Change in Range of Motion [ Time Frame: Change from baseline Range of Motion at postoperative1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181216


Contacts
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Contact: Yong In, MD, PhD 821090445228 iy1000@catholic.ac.kr
Contact: Mansoo Kim, MD, PhD 821072333875 kms3779@naver.com

Sponsors and Collaborators
The Catholic University of Korea
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Responsible Party: Yong In, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT04181216    
Other Study ID Numbers: Anatomically aligned TKRA
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases