Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS

Study Overview
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Brief Summary
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TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.

Official Title
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Comparison of Unilateral or Bilateral Fixation Using Pedicle Screws and TLIF in the Treatment of Lumbar Foraminal Stenosis

Conditions
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Lumbar Foraminal Stenosis

Intervention / Treatment
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* Procedure: TLIF and unilateral pedicle screw fixation
* Procedure: TLIF and bilateral pedicle screw fixation
* Device: Pedicle screw and cage


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Signed informed consent. Patient is willing to be available for each examination scheduled over the study duration. Lumbar foraminal stenosis diagnosed by patient history, physical examination and image confirmation. Patient has symptoms referable to the stenosis level (low back pain, leg pain, tingling, numbness or weakness), which are relieved after a selective nerve root block. Has not responded to conservative treatment for a period of 3 months (e.g. bed rest, physical therapy, medication, manipulations, other). Exclusion Criteria: Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis). Has presence of active malignancy Has a history of severe allergy Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate. Pregnant, or may become pregnant within follow-up period of study Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease) Spondylolisthesis at the target level Has undergone previous lumbar surgery Has severe osteoporosis (T-score ≤ -3.5) BMI > 35kg/m2 Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids. Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unilateral fixation<br>Patients undergoing TLIF and unilateral pedicle screw fixation | Procedure: TLIF and unilateral pedicle screw fixation<br>* TLIF combined with posterior unilateral pedicle screw fixation<br>Device: Pedicle screw and cage<br>* Pedicle screw and cage<br>|
| Active Comparator: Bilateral fixation<br>Patients undergoing TLIF and bilateral pedicle screw fixation | Procedure: TLIF and bilateral pedicle screw fixation<br>* TLIF combined with posterior bilateral pedicle screw fixation<br>Device: Pedicle screw and cage<br>* Pedicle screw and cage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) scores |  | 2 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events related to procedure |  | 2 years postoperatively | 
| Operative duration |  | 1 week postoperatively | 
| Estimated blood loss |  | 1 week postoperatively | 
| Length of hospital stay |  | 1 week after discharge | 
| Spinal angles | Radiographic parameters | 2 years postoperatively | 
| Intervertebral space height | Radiographic parameters | 2 years postoperatively | 
| Foraminal height | Radiographic parameters | 2 years postoperatively | 
| Cost of treatment |  | 2 years postoperatively | 
| Fusion rate |  | 2 years postoperatively | 
| Oswestry Disability Index (ODI) |  | 2 years postoperatively |