Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04419116 |
| Other study ID # |
MTU-EC-OT-1-137/62 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2018 |
| Est. completion date |
November 1, 2022 |
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 mobile bearing unicompartmental knee arthroplasty has shown excellent clinical outcome
and survivorship. However, some studies have shown that the patients still had medial knee
pain and shown worst the clinical outcome, even though the survivorship was excellent. The
medial knee pain after operation was the one cause of revision. The incidence of medial knee
pain was 0%-9%. The cause of medial knee pain was overloading on the medial plateau, local
inflammation, over hanging of the tibial component and overstretching of the MCL due to the
application of excessive polyethylene. Therefore, the tibia in this study was cut with under
resection technique for reducing the overloading on the medial tibial plateau. The purpose of
this study is to compare medial knee pain between tibial bone cut preservation technique and
conventional tibial bone cut technique following mobile bearing UKA.
Description:
A randomized control trial study was conducted at Thammasat University hospital, Thailand.
The inclusion criteria were patients with medial osteoarthritis (OA) of the knee with an
Alhback score of 2, 3 and 4, who were older than 50 years of age, with a range of movement
(ROM) > 90°, a varus deformity < 25°, and flexion contracture < 20° who underwent a medial
mobile bearing UKA (Oxford UKA; Zimmer Biomet, Inc, Warsaw, IN, USA), performed by a single
surgeon. The exclusion criteria were patients with a diagnosis of spontaneous osteonecrosis
of the knee (SPONK), intraoperative anterior cruciate ligament (ACL) insufficiency,
inflammatory joint disease, gout, post-traumatic arthritis, and primary PF arthritis. The
patients were randomized with computer technique into 2 groups, group (gp) I, conventional
tibial bone cut technique and gp II, tibial bone cut preservation technique. The baseline
patient characteristics included age, sex, site, the Knee Society Score© (KSS) (knee score,
pain score, and functional score), Oxford knee score (OKS), KOOS, Kujara score, body mass
index (BMI), degree of varus deformity, flexion contracture, genu recurvatum, and range of
motion (ROM) were recorded. The patients were followed up at 2 weeks, 6 weeks, 3months,
6months, 1 years, and annually. The VAS ofr medial knee and incidence of medial knee pain
were assessed in a blinded fashion by a research assistant at each visit using VAS scale
(0-10). The KSS, OKS, KOOS, and Kujara score also were recorded. At each follow-up, the
patients underwent AP standing, lateral standing, skyline view, and long-leg radiographs and
the component alignment, tibiofemoral angle and joint line of femur and tibia recorded.
