- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04183985
Comparison of Radiological, Clinical, Functional Outcomes Between Anatomically Aligned Total Knee Arthroplasty and Conventional Total Knee Arthroplasty
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 same-day bilateral total knee arthroplasty. A patient undergoing same-day bilateral total knee arthroplasty will use a random number to determine the instruments(JII-BCS or Legion), and both knee joints will be operated with the same instruments. Radiologic parameter, patients preference and clinical results was investigated in patients who received TKA during minimum 2 year follow up.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anatomically aligned total knee arthroplasty
Use anatomically aligned total knee arthroplasty implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith & Nephew) in patients undergoing same-day bilateral total knee arthroplasty.
|
In patients undergoing same-day bilateral total knee arthroplasty, after deciding the implant of TKA(anatomically aligned TKA implant or conventaional TKA implant) using random number table, compare the result of clinical outcome about two instruments.
|
ACTIVE_COMPARATOR: Conventaional total knee arthroplasty
Use conventional total knee arthroplasty implant (Legion total knee system, Smith & Nephew) in patients undergoing same-day bilateral total knee arthroplasty.
|
In patients undergoing same-day bilateral total knee arthroplasty, after deciding the implant of TKA(anatomically aligned TKA implant or conventaional TKA implant) using random number table, compare the result of clinical outcome about two instruments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Time Frame: Change from baseline score to score of postoperative1 year
|
Change from baseline score to score of postoperative1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Knee Society Score
Time Frame: Change from baseline score to score of postoperative1 year
|
Change from baseline score to score of postoperative1 year
|
Change in Range of Motion
Time Frame: Change from baseline Range of Motion at postoperative1 year
|
Change from baseline Range of Motion at postoperative1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Anatomically aligned TKRA2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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