A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis, Anatomically Aligned Total Knee Arthroplasty
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
Conventaional total knee arthroplasty
Arm Description
Use anatomically aligned TKA implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith & Nephew) in patients undergoing unilateral TKA
Use conventional TKA implant (Legion total knee system, JII-BCS, Smith & Nephew) in patients undergoing unilateral TKA
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
NCT04181528
First Posted
October 31, 2019
Last Updated
November 26, 2019
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04181528
Brief Title
A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty
Official Title
A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty
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 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.
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
Arm Type
Experimental
Arm Description
Use anatomically aligned TKA implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith & Nephew) in patients undergoing unilateral TKA
Arm Title
Conventaional total knee arthroplasty
Arm Type
Active Comparator
Arm Description
Use conventional TKA implant (Legion total knee system, JII-BCS, Smith & Nephew) in patients undergoing unilateral TKA
Intervention Type
Device
Intervention Name(s)
Total knee arthroplasty implant
Intervention Description
In patients undergoing unilateral TKA, decide the implant of TKA (anatomically aligned or conventional TKA implant) will be decided using ramdon number table
Primary Outcome Measure Information:
Title
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Time Frame
hange 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 Mansoo, MD, PhD
Phone
821072333875
Email
kms3779@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong In, MD, PhD
Organizational Affiliation
the Catholic Univerisity of Korea Seoul St Mary's hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty
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