Back to resultsComparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis
Primary Purpose
Lumbar Spondylolisthesis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Posterior lumbar interbody fusion
Inter transverse bone grafting
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spondylolisthesis
Eligibility Criteria
Inclusion Criteria:
- lumbar spondylolisthesis
Exclusion Criteria:
- infection of lumbar spine
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lumbar spondylolisthesis1
Lumbar spondylolisthesis 2
Arm Description
Outcomes
Primary Outcome Measures
Back pain
Back pain severity grading mild, moderate, severe
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03271060
Brief Title
Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis
Official Title
Comparative Study Between Posterior Lumbar Interbody Fusion(PLF) and Intertransverse Process Fusion in Treatment of Spodylolithesis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
August 30, 2018 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The first technique described for interbody fusion was the anterior lumbar interbody fusion (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal or transperitoneal approach.
While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's, Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).
Detailed Description
In this study we will try to identify the benefits and outcome of posterior lumbar interbody fusion and inter transverse process bone graft fusion.
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
Single Group Assignment
Model Description
Posterior inter body fusion and inter transverse process bone graft
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lumbar spondylolisthesis1
Arm Type
Active Comparator
Arm Title
Lumbar spondylolisthesis 2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Posterior lumbar interbody fusion
Intervention Description
Lumbar fusion by screws and inter vertebral cage
Intervention Type
Procedure
Intervention Name(s)
Inter transverse bone grafting
Intervention Description
Inter transverse process bone grafting by bone graft from illiac crest or other sites
Primary Outcome Measure Information:
Title
Back pain
Description
Back pain severity grading mild, moderate, severe
Time Frame
1year postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lumbar spondylolisthesis
Exclusion Criteria:
infection of lumbar spine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Garamoun, Resident
Phone
201091123869
Email
Garamoun.mahmoud@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis
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