MedTrace Logo

Comparison of Radiological, Clinical, Functional Outcomes Between Anatomically Aligned Total Knee Arthroplasty and Conventional Total Knee Arthroplasty

NCT04183985 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-12-03

No results posted yet for this study

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 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.

Conditions

  • Knee Arthropathy
  • Anatomically Aligned Total Knee Arthroplasty

Interventions

DEVICE

Total knee arthroplasty prosthesis

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.

Sponsors & Collaborators

  • The Catholic University of Korea

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-12-31
Completion
2022-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04183985 on ClinicalTrials.gov