Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly and Formulation on Treatment Principles
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Body angle
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
group3
participant with PLIF and TKA on one stage
干预措施: PLIF (Procedure)
group3
participant with PLIF and TKA on one stage
干预措施: TKA (Procedure)
group1
participant with posterior lumbar interbody fusion(PLIF or PLF)
干预措施: PLIF (Procedure)
group2
participant with total knee arthroplasty (TKA)
干预措施: TKA (Procedure)
group4
participant without operation
结局指标
主要结局
Body angle
时间窗: 6 months
Body angle is defined an angle of the shoulder and femoral trochanter connection and the greater trochanter and knee lateral condyle connection.
次要结局
- Lumbar spinal area(6 months)
- Lumbar lordosis angle (LL)(6 months)
- knee extension angle(6 months)
研究者
Liu Haiying
Department of spinal surgery
Peking University People's Hospital