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临床试验/NCT01353885
NCT01353885终止不适用

Outcomes Following Anterior Approach to Total Hip Arthroplasty: A Multi-Centre Observational Cohort Study

McMaster University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
50
试验地点
1
主要终点
Patient Functional Ability

研究概览

简要总结

Osteoarthritis disables approximately 10% of people who are 60 years or older and compromises the quality of life of more than 20 million Americans every year. Osteoarthritis is caused by the breakdown of cartilage that lines the bones at your joints from daily wear and tear and results in pain and restricted function. Total hip arthroplasty (THA) or total hip replacement, is currently one of the most successful and cost-effective treatments used to eliminate pain and restore function in those suffering from osteoarthritis. There are multiple ways to perform a THA. The main difference between each type is the point of incision in relation to a muscle on the outer surface of your hip bone: gluteus medius. The incision performed can be anterior (in front of the muscle), anterolateral (in front and to the side of the muscle), or posterior (from the back). Each of these approaches has its own advantages and disadvantages, but there is no evidence available that makes one better than the other. The purpose of this study is to determine which of the three approaches to THA is the most effective. The main outcome that will determine the most effective approach is the functional ability of the patients included in this study at 52 weeks. The investigators will also compare whether the patient's: length of hospital stay, use of assistive devices, need for revision surgery, ability to return to work, ability to relieve pain, complication rate, and quality of life. The investigators hypothesize that the anterior approach will be the most effective approach in reducing the rate of post-operative complications after THA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Men or women who are 18 years of age or older.
  • Primary diagnosis of hip arthritis (radiographically and clinically).
  • Patients undergoing an unilateral THA.
  • Provision of informed consent by patient.

排除标准

  • Patients being managed with alternative approaches (other than anterior, anterolateral or posterior THA) will be excluded.
  • Patients undergoing a revision THA.
  • Patients undergoing a bilateral THA.
  • Patients with infection around the hip (soft tissue or bone).
  • Patients who have had previous major hip surgery (hip arthroscopy is permitted) or hardware implanted in their hip.
  • Patients who are currently enrolled in another surgical intervention trial.
  • Patient has cognitive or language barriers that would limit completion of quality of life, pain, and function questionnaires in English.
  • Anticipated problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.

结局指标

主要结局

Patient Functional Ability

时间窗: 52 Weeks

Measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaire.

次要结局

  • Ability to participate in sports activities(52 weeks)
  • Use of Assistive Device(52 weeks)
  • Revision Surgery(52 weeks)
  • Technical Parameters(1 day - measured during and post-operatively)
  • Return to Work(52 Weeks)
  • Complication Rate(52 Weeks)
  • Pain(52 Weeks)
  • Quality of Life(52 Weeks)
  • Length of Hospital Stay(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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