Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly and Formulation on Treatment Principles

Conditions
-----------------
Lumbar Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: PLIF
* Procedure: TKA


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group1<br>participant with posterior lumbar interbody fusion(PLIF or PLF) | Procedure: PLIF<br>* 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.<br>|
| Experimental: group2<br>participant with total knee arthroplasty (TKA) | Procedure: TKA<br>* 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.<br>|
| Experimental: group3<br>participant with PLIF and TKA on one stage | Procedure: PLIF<br>* 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.<br>Procedure: TKA<br>* 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.<br>|
| No Intervention: group4<br>participant without operation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body angle | Body angle is defined an angle of the shoulder and femoral trochanter connection and the greater trochanter and knee lateral condyle connection. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar lordosis angle (LL) | Lumbar lordosis angle | 6 months | 
| Lumbar spinal area | measured by CT(GE light speed QX/i) | 6 months | 
| knee extension angle | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee - spine syndrome, PLIF, TKA, sagittal parameters, neuroelectrophysiology