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临床试验/NCT01495546
NCT01495546Unknown不适用

Randomized Comparison of Quality of Life and Functional Patients Undergoing Total Hip Replacement Uncemented. Load Early X Load Late

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
45
试验地点
1
主要终点
Recovery time after THA

研究概览

简要总结

In Brazil, several hip surgeries performed, especially total knee arthroplasty, which represents 1.5 million procedures (Penedo, New, 2007). The rehabilitation of these individuals is slow with respect to the march because it requires an aid and not to use the operated leg as support for three weeks, according to conventional methods. After the third week, the support becomes part and after that period (sixth week), the support becomes total. Therefore, and in order to provide better quality of life, the goal of this work is to compare the march in 40 patients divided into two groups of 20 subjects each. In the control group, the treatment approach is the traditional, i.e., without immediate loading, while the other charge will be applied immediately in the operated limb. In order to verify the possible gain in the quality of life of these patients, the SF-36 will be applied. The march will be assessed with the Time Up and Go test and the force platform and the Harris Hip score analyze the function of the hip. Individuals will receive such care at the Institute of Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of São Paulo (IOT - HC - USP). The results of comparisons between the two groups and the clinical findings obtained will be subjected to appropriate statistical tests, guided by the principles of evidence-based clinical practice, seeking to facilitate and improve the lives of these individuals so they can move freely.

研究设计

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

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients served by the institution with THA without cement;
  • BMI less than 40, ie, present in most class II obesity;
  • Patients with diseases such as osteoarthritis and osteonecrosis of the femoral head;
  • Absence of systemic involvement;
  • Patients with prosthetic type Lépine.

排除标准

  • Bilateral arthroplasty;
  • Partial arthroplasty;
  • Arthroplasties for review;
  • Cemented arthroplasties;
  • Surgical complications.

研究组 & 干预措施

Early loading

Experimental

干预措施: Early loading (Other)

late loading

Active Comparator

干预措施: Late loading (Other)

结局指标

主要结局

Recovery time after THA

时间窗: Until 6 weeks

Patients will be evaluated in the following periods: THA pre-surgery, the third day post-surgery THA, third and sixth week post-surgery THA, third and sixth months after surgery THA

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

Gisele Pucci Mantelli

Physiotherapist

University of Sao Paulo

研究点 (1)

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