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临床试验/NCT04419116
NCT04419116Unknown不适用

Faculty of Medicine, Thammasat University

Thammasat University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
visual analog scale (VAS) for pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • medial osteoarthritis of knee

排除标准

  • posttraumatic arthritis
  • Rheumatoid arthritis
  • anterior cruciate ligament insufficiency
  • osteonecrosis of knee

结局指标

主要结局

visual analog scale (VAS) for pain

时间窗: 2 years

pain at medial tibial plateau

次要结局

  • knee society score(2 years)
  • Kujala score(2 years)
  • knee injury osteoarthritis outcome score(2 years)
  • Oxford knee score(2 years)
  • joint forgotten score(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Boonchana Pongcharoen

Associated professor

Thammasat University

研究点 (2)

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