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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
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients diagnosed LSS need to be underwent PLIF or PLF
  2. and Patients who need surgery and are limited by knee extension greater than 10 °
  3. ineffective conservative treatment for 6 months
  4. patients have never relevant surgery before
  5. Participants will be volunteered randomly assigned to surgery group and observation group.

Exclusion Criteria:

  1. People have had similar lumbar or knee surgery
  2. patients with lumbar or knee joint tumor or congenital malformation
  3. 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

    First Posted
    November 25, 2017
    Last Updated
    December 1, 2017
    Sponsor
    Peking University People's Hospital
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    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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