Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

Study Overview
=================
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.

Official Title
-----------------
Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

Conditions
-----------------
Lumbar Spondylolisthesis

Intervention / Treatment
-----------------
* Procedure: Bilateral decompression with TLIF
* Procedure: laminectomy with PLIF
* Device: Pedicle screw and interbody cage


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral decompression with TLIF<br>Patients undergoing bilateral decompression with TLIF | Procedure: Bilateral decompression with TLIF<br>* Bilateral decompression of neural elements combined with TLIF<br>Device: Pedicle screw and interbody cage<br>* Pedicle screw and interbody cage<br>|
| Active Comparator: laminectomy with PLIF<br>Patients undergoing laminectomy with PLIF | Procedure: laminectomy with PLIF<br>* Decompression of neural elements using laminectomy combined with PLIF<br>Device: Pedicle screw and interbody cage<br>* Pedicle screw and interbody cage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale for low back pain and leg pain |  | 2 years postoperatively | 
| Oswestry disability index |  | 2 years postoperatively | 
| Zurich claudication questionnaire |  | 2 years postoperatively | 
| SF-36 score |  | 2 years postoperatively | 
| Fusion rate |  | 2 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery procedure duration |  | Intraoperation | 
| Estimated blood loss |  | Intraoperation | 
| Length of postoperative hospital stay |  | 1 week after hospital discharge | 
| Complication |  | 2 years postoperatively | 
| Degree of spondylolisthesis measured by X ray |  | 2 years postoperatively | 
| Disc space height measured by X ray |  | 2 years postoperatively | 
| Lumbar lordosis measured by X ray |  | 2 years postoperatively |