Back to resultsClinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis
Primary Purpose
Lumbar Spondylolisthesis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bilateral decompression with TLIF
laminectomy with PLIF
Pedicle screw and interbody cage
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spondylolisthesis
Eligibility Criteria
Inclusion Criteria:
- lumbar spondylolisthesis
- symptoms of low back pain and/or neurogenic claudication with or without radiculopathy referable to the lumbar spine,
- at least 3 months of failed conservative therapies
Exclusion Criteria:
- multilevel lumbar degenerative diseases
- history of previous lumbar surgery
Sites / Locations
- Department of Orthopedic Surgery, Shanghai Ninth People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bilateral decompression with TLIF
laminectomy with PLIF
Arm Description
Patients undergoing bilateral decompression with TLIF
Patients undergoing laminectomy with PLIF
Outcomes
Primary Outcome Measures
visual analog scale for low back pain and leg pain
Oswestry disability index
Zurich claudication questionnaire
SF-36 score
Fusion rate
Secondary Outcome Measures
Surgery procedure duration
Estimated blood loss
Length of postoperative hospital stay
Complication
Degree of spondylolisthesis measured by X ray
Disc space height measured by X ray
Lumbar lordosis measured by X ray
Full Information
NCT ID
NCT02972190
First Posted
November 7, 2016
Last Updated
November 24, 2016
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT02972190
Brief Title
Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis
Official Title
Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
5. Study Description
Brief Summary
Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft-tissue structures. The investigators plan to compare the clinical and radiographic outcomes of bilateral decompression with transforaminal lumbar interbody fusion and laminectomy with posterior lumbar interbody fusion in the treatment of degenerative spondylolisthesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spondylolisthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bilateral decompression with TLIF
Arm Type
Experimental
Arm Description
Patients undergoing bilateral decompression with TLIF
Arm Title
laminectomy with PLIF
Arm Type
Active Comparator
Arm Description
Patients undergoing laminectomy with PLIF
Intervention Type
Procedure
Intervention Name(s)
Bilateral decompression with TLIF
Intervention Description
Bilateral decompression of neural elements combined with TLIF
Intervention Type
Procedure
Intervention Name(s)
laminectomy with PLIF
Intervention Description
Decompression of neural elements using laminectomy combined with PLIF
Intervention Type
Device
Intervention Name(s)
Pedicle screw and interbody cage
Intervention Description
Pedicle screw and interbody cage
Primary Outcome Measure Information:
Title
visual analog scale for low back pain and leg pain
Time Frame
2 years postoperatively
Title
Oswestry disability index
Time Frame
2 years postoperatively
Title
Zurich claudication questionnaire
Time Frame
2 years postoperatively
Title
SF-36 score
Time Frame
2 years postoperatively
Title
Fusion rate
Time Frame
2 years postoperatively
Secondary Outcome Measure Information:
Title
Surgery procedure duration
Time Frame
Intraoperation
Title
Estimated blood loss
Time Frame
Intraoperation
Title
Length of postoperative hospital stay
Time Frame
1 week after hospital discharge
Title
Complication
Time Frame
2 years postoperatively
Title
Degree of spondylolisthesis measured by X ray
Time Frame
2 years postoperatively
Title
Disc space height measured by X ray
Time Frame
2 years postoperatively
Title
Lumbar lordosis measured by X ray
Time Frame
2 years postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lumbar spondylolisthesis
symptoms of low back pain and/or neurogenic claudication with or without radiculopathy referable to the lumbar spine,
at least 3 months of failed conservative therapies
Exclusion Criteria:
multilevel lumbar degenerative diseases
history of previous lumbar surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofei Cheng, MD
Phone
8613917556604
Email
chengxf2015@163.com
Facility Information:
Facility Name
Department of Orthopedic Surgery, Shanghai Ninth People's Hospital
City
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofei Cheng, MD
Phone
8613917556604
Email
chengxf2015@163.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis
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