Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly
Primary Purpose
Lumbar Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PLIF
TKA
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Osteoarthritis focused on measuring knee - spine syndrome, PLIF, TKA, sagittal parameters, neuroelectrophysiology
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
group1
group2
group3
group4
Arm Description
participant with posterior lumbar interbody fusion(PLIF or PLF)
participant with total knee arthroplasty (TKA)
participant with PLIF and TKA on one stage
participant without operation
Outcomes
Primary Outcome Measures
Body angle
Body angle is defined an angle of the shoulder and femoral trochanter connection and the greater trochanter and knee lateral condyle connection.
Secondary Outcome Measures
Lumbar lordosis angle (LL)
Lumbar lordosis angle
Lumbar spinal area
measured by CT(GE light speed QX/i)
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.
Full Information
NCT ID
NCT03364790
First Posted
November 25, 2017
Last Updated
December 1, 2017
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03364790
Brief Title
Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly
Official Title
Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly and Formulation on Treatment Principles
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Osteoarthritis
Keywords
knee - spine syndrome, PLIF, TKA, sagittal parameters, neuroelectrophysiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group1
Arm Type
Experimental
Arm Description
participant with posterior lumbar interbody fusion(PLIF or PLF)
Arm Title
group2
Arm Type
Experimental
Arm Description
participant with total knee arthroplasty (TKA)
Arm Title
group3
Arm Type
Experimental
Arm Description
participant with PLIF and TKA on one stage
Arm Title
group4
Arm Type
No Intervention
Arm Description
participant without operation
Intervention Type
Procedure
Intervention Name(s)
PLIF
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
TKA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body angle
Description
Body angle is defined an angle of the shoulder and femoral trochanter connection and the greater trochanter and knee lateral condyle connection.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Lumbar lordosis angle (LL)
Description
Lumbar lordosis angle
Time Frame
6 months
Title
Lumbar spinal area
Description
measured by CT(GE light speed QX/i)
Time Frame
6 months
Title
knee extension angle
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuai Xu
Phone
(86)18811792718
Email
1204649202@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haiying Liu
Organizational Affiliation
Department of spinal surgery
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11795726
Citation
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.
Results Reference
background
PubMed Identifier
15507807
Citation
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.
Results Reference
background
PubMed Identifier
12585585
Citation
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.
Results Reference
background
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Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly
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