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Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement

2020年3月26日 更新者：Wade Gofton、Ottawa Hospital Research Institute

Examining Effects of Spinal Arthrodesis on Outcomes Following Total Hip Arthroplasty

The purpose of the study is to explore the long term functional status of people who have had both a spinal fusion procedure and a total hip replacement.

研究概览

地位

未知

条件

干预/治疗

详细说明

The purpose of the study is to explore the long term functional status of people who have had both a spinal fusion procedure and a total hip replacement. Studies have found that those who have received spinal fusion may have worse outcomes following a total hip replacement than those who have not received a spinal fusion. The information obtained from this study will allow surgeons and researchers to better understand why some who've had a spine fusion have more complications post total hip replacement compared to those who did not have spinal fusion surgery.

研究类型

观察性的

注册 (预期的)

160

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Ontario
      • Ottawa、Ontario、加拿大、K1Y4E9
        • 招聘中
        • Ottawa Hospital Research Institute
        • 接触：
          • Research Manager
          • 电话号码：613-737-8920
        • 首席研究员：
          • Wade Gofton, MD FRCSC MEd
        • 副研究员：
          • Paul Beaule, MD FRCSC
        • 副研究员：
          • George Grammatopoulos, BMBBS DPhil Oxon MRCS FRCS
        • 副研究员：
          • Matthew Coyle, MD
        • 副研究员：
          • Mario Lamontagne, PhD
        • 副研究员：
          • Philippe Phan, MD PhD FRCSC

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Approximately 70 patients who underwent total hip arthroplasty (THA) and spine fusion (SF) surgery will be called by the surgeon or research team and asked if they wish to participate in the study. A second group of approximately 45 patients who have only had a THA (and no SF) will serve as a comparison group. A third group of approximately 45 patients who have only had an SF surgery (and no THA) will also be recruited.

描述

Inclusion Criteria:

  • Willing to come to the Civic Campus for a surgical follow-up visit
  • Speaks English and/or French
  • Group 1 patients must have had a spine fusion (SF) and total hip arthroplasty (THA)
  • Group 2 patients must have had a total hip replacement (THA) and no history of spine fusion (SF)
  • Group 3 patients must have had a spine fusion (SF) and no history of total hip arthroplasty (THA)

Exclusion Criteria:

  • Patient does not meet all 'inclusion' criteria
  • Patient is unable to answer questionnaires
  • Unable to get x-rays for other medical reasons
  • Severe dementia

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Spine Fusion and Total Hip Replacement
Any patient who has undergone spine fusion (SF) and total hip arthroplasty (THA). Patients will undergo x-ray imaging and complete functional assessment questionnaires. Patients may additionally be asked to participate in a gait analysis in a Human Movement Laboratory.
诊断测试：X-Ray Imaging
X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.
其他：Gait Analysis
Certain patients may be asked to participate in a motion analysis procedure at the Human Movement Laboratory at the University of Ottawa. This procedure takes approximately 1.5 hours and you will only be asked to participate in the motion analysis procedure once. Participants will change into a custom-designed tight body suit, which has reflective markers on its surface for infrared video capture. Participants will then have pairs of surface electromyography (EMG) electrodes placed on certain areas of the skin on the legs and on the back. Wearing the EMG electrodes and marker suit, participants will perform 5 trials of walking on a level walkway, walking up and down a 3-step staircase, sitting from a standing position, and standing from a seated position.
Total Hip Replacement Group
Any patient who has had THA only (no spine fusion surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires. Patients may additionally be asked to participate in a gait analysis in a Human Movement Laboratory.
诊断测试：X-Ray Imaging
X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.
其他：Gait Analysis
Certain patients may be asked to participate in a motion analysis procedure at the Human Movement Laboratory at the University of Ottawa. This procedure takes approximately 1.5 hours and you will only be asked to participate in the motion analysis procedure once. Participants will change into a custom-designed tight body suit, which has reflective markers on its surface for infrared video capture. Participants will then have pairs of surface electromyography (EMG) electrodes placed on certain areas of the skin on the legs and on the back. Wearing the EMG electrodes and marker suit, participants will perform 5 trials of walking on a level walkway, walking up and down a 3-step staircase, sitting from a standing position, and standing from a seated position.
Spine Fusion Only Group
Any patient who has had spine fusion only (no hip replacement surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires.
诊断测试：X-Ray Imaging
X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Implant positioning
大体时间：6months or greater post-operative
Radiographic assessment (x-ray cup orientation measurements)
6months or greater post-operative

次要结果测量

结果测量
措施说明
大体时间
Hip dysfunction and osteoarthritis outcome score (HOOS)
大体时间：6months or greater post-operative
Disease-specific quality of life measure
6months or greater post-operative
Oxford Hip Score
大体时间：6months or greater post-operative
Disease-specific quality of life measure
6months or greater post-operative
SF-12 Questionnaire
大体时间：6months or greater post-operative
Patient-reported overall quality of life measure
6months or greater post-operative
Oswestry low back disability questionnaire
大体时间：6months or greater post-operative
Assessment of low back pain
6months or greater post-operative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ottawa Hospital Research Institute

调查人员

  • 首席研究员：Wade Gofton, MD, FRCSC、The Ottawa Hospital Research Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年5月15日

初级完成 (预期的)

2020年11月1日

研究完成 (预期的)

2021年6月1日

研究注册日期

首次提交

2017年7月21日

首先提交符合 QC 标准的

2017年8月1日

首次发布 (实际的)

2017年8月7日

研究记录更新

最后更新发布 (实际的)

2020年3月30日

上次提交的符合 QC 标准的更新

2020年3月26日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 20170312

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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