Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04419129 |
| Other study ID # |
ThmmasatU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2017 |
| Est. completion date |
December 1, 2020 |
Study information
| Verified date |
August 2021 |
| Source |
Thammasat University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The total knee replacement (TKA) has shown excellent survival. However, some patients were up
to 20%, they still had pain and make them dissatisfy after operation. The medial
unicompartmental knee arthroplasty (UKA) also has shown excellent survivorship. The patient
who underwent UKA fell like normal knee because restoring natural kinematic and biomechanic
compare to TKA. However, The previous studies did not include the same characteristic of
patient in their studies. Therefor, UKA should be better than TKA. This study will compare
TKA to mobile bearing medial UKA or Oxford medial UKA. The mobile bearing UKA is different to
fixed bearing UKA. The mobile bearing UKA will be back knee alignment to pre-disease stage,
restore knee stability and restore natural knee kinematic and biomechanic. Therefore,
patients who underwent mobile bearing UKA will feel like normal knee and restore function to
near or nearly normal. The measurement of clinical outcome after knee arthroplasty is
questionable. The self-report questionnaire was used in the past. However, this score can not
estimate the true function of patients. The patient have shown high score, but they still had
pain and did not show satisfy after operation.The performance-based test such as 2-minute
walk test (2MWT), 6-minute walk test (6MWT) and Timed get-up-and-go test (TUG) should show
the exactly clinical outcome of patient following knee arthroplasty compare to self-report
questionnaire. Today, no randomized controlled trial study to compare performance-based test
between TKA and mobile bearing UKA. Therefor, this study will compare 2MWT and TUG between
TKA and mobile bearing UKA in medial OA knee.
Description:
The inclusion criteria were patients with medial of the knee with an Alhback score of 2, 3 or
4, those who were older than 40 years of age, those with a range of motion (ROM) > 90°, those
with a varus deformity < 25°, and those with a flexion contracture < 20°. They were
randomized into 2 groups using computer program. Group I was 50 UKAs and group II was 50
TKAs. All patients in group I received medial mobile-bearing UKA (Oxford® UKA; Zimmer Biomet,
Inc, Warsaw, IN, USA) and group II received posterior stabilized fixed bearing total knee
arthroplasty (Vanguard®; Zimmer Biomet, Inc, Warsaw, IN, USA). The exclusion criteria were
patients with a diagnosis of spontaneous osteonecrosis of the knee (SPONK), intraoperative
anterior cruciate ligament (ACL) insufficiency or completely rupture of ACL, inflammatory
joint disease, gout, posttraumatic arthritis, or primary patellofemoral arthritis.The
recorded baseline patient characteristics included age and sex and the knee side, Knee
Society Score (KSS), Oxford Knee Score (OKS), Knee Injury and Osteoarthritis Outcome Score
(KOOS),(2MWT), (6MWT), (TUG), body mass index (BMI), degree of varus deformity, degree of
flexion contracture, genu recurvatum, and ROM. Patients were followed at 6 weeks, 3 months, 6
months, and 1 year and then annually thereafter. At each follow-up, the following data were
recorded: Joint Forgotten Score (JFS), KSS, OKS, Knee Injury and Osteoarthritis Outcome Score
(KOOS), Kujala score, (2MWT), (TUG), ROM and knee alignment. In addition, the following knee
X-rays were performed: anteroposterior (AP) and lateral standing, skyline and long-leg views;
from these, the tibiofemoral angles were measured. Complications such as infection, component
loosening, fractures, and bearing dislocations were also recorded. We determined differences
in the KSS, OKS, KOOS, JFS, Kujala score,(2MWT), (TUG),ROM, tibiofemoral angle, flexion
contractures, and genu recurvatum using Student's t tests. All analyses were two sided, and a
p value of ≤ 0.05 denoted statistical significance.
