A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty

The Catholic University of Korea

Status: Unknown

Conditions: Anatomically Aligned Total Knee Arthroplasty; Knee Osteoarthritis

Treatments: Device: Total knee arthroplasty implant

Study type: Interventional

Funder types: Other

Identifiers

NCT04181528

Anatomically aligned TKRA3

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Anatomically aligned total knee arthroplasty

Experimental group

Description:

Use anatomically aligned TKA implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith \& Nephew) in patients undergoing unilateral TKA

Treatment:

Device: Total knee arthroplasty implant

Conventaional total knee arthroplasty

Active Comparator group

Description:

Use conventional TKA implant (Legion total knee system, JII-BCS, Smith \& Nephew) in patients undergoing unilateral TKA

Treatment:

Device: Total knee arthroplasty implant