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临床试验/NCT02854189
NCT02854189已完成不适用

Department of Orthopaedics Faculty of Medicine Thammasat University Thailand

Thammasat University0 个研究点目标入组 104 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
主要终点
hyperextension angle, the incidence of postoperative genu recurvatum

研究概览

简要总结

The purpose of this study is to explore the effects of the Oxford unicompartmental knee arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure and one without. Specifically, this study compare the number of occurrences of postoperative genu recurvatum and the postoperative hyperextension angles among the patients. Additionally, the knee scores, the pain scores, and the functional scores for the two groups of patients are compared.

Materials and methods: This study prospectively followed 104 patients (114 knees) who had been treated with cemented minimally invasive surgery unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up. The patients were divided into two groups: those without preoperative genu recurvatum (85 patients; 94 knees) and those with preoperative genu recurvatum (19 patients; 20 knees). The incidence of the postoperative genu recurvatum, the postoperative hyperextension angles, the knee scores, the pain scores, and the functional scores were recorded and compared between two groups..

详细描述

The patients in both groups were applied with cemented Oxford unicompartmental knee arthroplasty with the same surgeon. The all patients were performed surgery with minimally invasive surgery technique. The gender, site, range of motion, alignment of prosthesis, operative time, blood loss, and posterior slope of tibial component also were recorded and compared between two groups. The incidence of postoperative genu recurvatum, gender, and site were computed using Fisher's exact test. The hyperextension angle, knee score, pain score, functional score,range of motion, alignment of prosthesis, posterior slope of tibial component, operative time, and blood loss were compared with student t-test.

研究设计

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

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The medial OA knee with older than 40 years of age, ROM greater than 90°, varus deformity less than 25°, and flexion contractures less than 20°

排除标准

  • patients who were diagnosed spontaneous osteonecrosis of knee (SPONK), patients with intraoperative ACL insufficiency, post traumatic arthritis, gouty arthritis, inflammatory joints.

结局指标

主要结局

hyperextension angle, the incidence of postoperative genu recurvatum

时间窗: 2 years

hyperextension angle, the incidence of postoperative genu recurvatum

次要结局

未报告次要终点

研究者

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

Boonchana Pongcharoen

Principal investigator

Thammasat University

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