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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04181528
• Other study ID #: Anatomically aligned TKRA3
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2019
• Source: The Catholic University of Korea
• Contact: Yong In, MD, PhD
• Phone: 821090445228
• Email: iy1000[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anatomically Aligned Total Knee Arthroplasty
• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Western Ontario and McMaster Universities Index(WOMAC index)		hange from baseline score to score of postoperative1 year
Secondary	Change in Knee Society Score		Change from baseline score to score of postoperative1 year
Secondary	Change in Range of Motion		Change from baseline Range of Motion at postoperative1 year