Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly
2017年12月1日 更新者：Liu Haiying、Peking University People's Hospital
Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly and Formulation on Treatment Principles
The study has before mentioned the concept of "knee - spine syndrome" domestically, on the basement of which, the new study intends to perform another further study on the relationship between lumbar and lower extremity degenerative diseases.
研究概览
详细说明
A prosepective, single-center, factorial design, randomized study will be performed.
In this study, the 120 participants with degenerative lumbar and knees disease coped with the standard were included, then were assigned into 4 groups randomly.
The patients in 3 operation groups were treated with posterior lumbar interbody fusion(PLIF or PLF) or total knee arthroplasty (TKA) or both of them in one stage respectively and the forth group with no surgery.
The comparison between observation and operation group and the difference on self-control pre-and post-operatively in operation group within 6 months were measured and valuated.
The result will be formed by the correlation and causal relationship on sagittal parameters on photograph, biomechanics, neuroelectrophysiology and molecular biology and the conclusions drawn by the use of modern medical basic research methods will formulate the treatment principles on it.
研究类型
介入性
注册 (预期的)
120
阶段
- 不适用
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
50年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients diagnosed LSS need to be underwent PLIF or PLF
- and Patients who need surgery and are limited by knee extension greater than 10 °
- ineffective conservative treatment for 6 months
- patients have never relevant surgery before
- Participants will be volunteered randomly assigned to surgery group and observation group.
Exclusion Criteria:
- People have had similar lumbar or knee surgery
- patients with lumbar or knee joint tumor or congenital malformation
- there are contraindications of surgery such as infections and serious illness.
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
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：group1
participant with posterior lumbar interbody fusion(PLIF or PLF)
|
Randomly include the 30 participants diagnosed LSS and knee arthritis or limited by knee extension greater than 10 °who need to be operated and then performed PLIF or PLF; include anothr ones of 30 need to be with the implementation of TKA;and another group with the same diagnosis will be underwent both of surgeries in one stage.
|
|
实验性的：group2
participant with total knee arthroplasty (TKA)
|
Randomly include the 30 participants diagnosed LSS and knee arthritis or limited by knee extension greater than 10 °who need to be operated and then performed PLIF or PLF; include anothr ones of 30 need to be with the implementation of TKA;and another group with the same diagnosis will be underwent both of surgeries in one stage.
|
|
实验性的：group3
participant with PLIF and TKA on one stage
|
Randomly include the 30 participants diagnosed LSS and knee arthritis or limited by knee extension greater than 10 °who need to be operated and then performed PLIF or PLF; include anothr ones of 30 need to be with the implementation of TKA;and another group with the same diagnosis will be underwent both of surgeries in one stage.
Randomly include the 30 participants diagnosed LSS and knee arthritis or limited by knee extension greater than 10 °who need to be operated and then performed PLIF or PLF; include anothr ones of 30 need to be with the implementation of TKA;and another group with the same diagnosis will be underwent both of surgeries in one stage.
|
|
无干预：group4
participant without operation
|
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 |
|---|---|---|
|
Body angle
大体时间：6 months
|
Body angle is defined an angle of the shoulder and femoral trochanter connection and the greater trochanter and knee lateral condyle connection.
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Lumbar lordosis angle (LL)
大体时间：6 months
|
Lumbar lordosis angle
|
6 months
|
|
Lumbar spinal area
大体时间：6 months
|
measured by CT(GE light speed QX/i)
|
6 months
|
|
knee extension angle
大体时间：6 months
|
The angle of knee extension the angle between the line connecting the greater trochanter of the femur and the lateral condyle of the femur and the line connecting the lateral condyle of the knee and the lateral condyle of the ankle.
|
6 months
|
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。
调查人员
- 首席研究员：Haiying Liu、Department of spinal surgery
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Murata Y, Takahashi K, Yamagata M, Hanaoka E, Moriya H. The knee-spine syndrome. Association between lumbar lordosis and extension of the knee. J Bone Joint Surg Br. 2003 Jan;85(1):95-9. doi: 10.1302/0301-620x.85b1.13389.
- Lin SI, Lin RM. Sensorimotor and balance function in older adults with lumbar nerve root compression. Clin Orthop Relat Res. 2002 Jan;(394):146-53. doi: 10.1097/00003086-200201000-00017.
- Matsuyama Y, Hasegawa Y, Yoshihara H, Tsuji T, Sakai Y, Nakamura H, Kawakami N, Kanemura T, Yukawa Y, Ishiguro N. Hip-spine syndrome: total sagittal alignment of the spine and clinical symptoms in patients with bilateral congenital hip dislocation. Spine (Phila Pa 1976). 2004 Nov 1;29(21):2432-7. doi: 10.1097/01.brs.0000143671.67779.14.
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 (预期的)
2018年1月1日
初级完成 (预期的)
2020年12月30日
研究完成 (预期的)
2020年12月30日
研究注册日期
首次提交
2017年11月25日
首先提交符合 QC 标准的
2017年12月1日
首次发布 (实际的)
2017年12月7日
研究记录更新
最后更新发布 (实际的)
2017年12月7日
上次提交的符合 QC 标准的更新
2017年12月1日
最后验证
2017年12月1日
更多信息
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