A Comparison of Anatomically Aligned Versus Conventional in Unilateral 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 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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis; Anatomically Aligned Total Knee Arthroplasty
• Intervention / Treatment: Device: Total knee arthroplasty implant

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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
Active Comparator: Conventaional total knee arthroplasty; Use conventional TKA implant (Legion total knee system, JII-BCS, Smith & Nephew) in patients undergoing unilateral TKA	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Western Ontario and McMaster Universities Index(WOMAC index)	hange from baseline score to score of postoperative1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Knee Society Score	Change from baseline score to score of postoperative1 year
Change in Range of Motion	Change from baseline Range of Motion at postoperative1 year

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Anatomically aligned TKRA3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No