Comparison of Anatomically Aligned and Conventional Total Knee Arthroplasty in the Same Patients
Primary Purpose
Knee Osteoarthritis, Anatomically Aligned Total Knee Arthroplasty
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anatomically aligned total knee arthroplasty implant
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
anatomically aligned total knee arthroplasty prosthesis
Conventaional total knee arthroplasty group
Arm Description
Total knee arthroplasty with anatomically aligned total knee arthroplasty implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith & Nephew)
Total knee arthroplasty with conventional total knee arthroplasty implant (Legion total knee system, Smith & Nephew)
Outcomes
Primary Outcome Measures
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Secondary Outcome Measures
Change in Knee Society Score
Change in Range of Motion
Full Information
NCT ID
NCT04181216
First Posted
October 30, 2019
Last Updated
November 26, 2019
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04181216
Brief Title
Comparison of Anatomically Aligned and Conventional Total Knee Arthroplasty in the Same Patients
Official Title
Comparison of Anatomically Aligned and Conventional Total Knee Arthroplasty in the Same Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Anatomically Aligned Total Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anatomically aligned total knee arthroplasty prosthesis
Arm Type
Experimental
Arm Description
Total knee arthroplasty with anatomically aligned total knee arthroplasty implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith & Nephew)
Arm Title
Conventaional total knee arthroplasty group
Arm Type
Active Comparator
Arm Description
Total knee arthroplasty with conventional total knee arthroplasty implant (Legion total knee system, Smith & Nephew)
Intervention Type
Device
Intervention Name(s)
Anatomically aligned total knee arthroplasty implant
Intervention Description
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 Measure Information:
Title
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Time Frame
Change from baseline score to score of postoperative1 year
Secondary Outcome Measure Information:
Title
Change in Knee Society Score
Time Frame
Change from baseline score to score of postoperative1 year
Title
Change in Range of Motion
Time Frame
Change from baseline Range of Motion at postoperative1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong In, MD, PhD
Phone
821090445228
Email
iy1000@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Mansoo Kim, MD, PhD
Phone
821072333875
Email
kms3779@naver.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Anatomically Aligned and Conventional Total Knee Arthroplasty in the Same Patients
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