Novel Technique Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage

Study Overview
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Brief Summary
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● Null hypothesis (H0): Unilateral pedicle screw with contralateral interbody cage has better outcomes than unilateral pedicle screw fixation with ipsilateral cage. ● Alternative hypothesis (H1): Unilateral pedicle screw with contralateral interbody cage gives the same outcomes as unilateral pedicle screw fixation with ipsilateral cage.

Detailed Description
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Lumber interbody fusion is one of the commonest neurosurgical procedures. A lot of studies showed the value of unilateral approach which resulted in less cost, time and radiation exposure when use interbody cage with ipsilateral pedicular screws fixation in comparison to bilateral approach when use interbody cage with bilateral pedicular screws fixation. Fusion rate, cage migration, and biomechanical stress were the main draw backs of unilateral approach by lumber interbody fusion with ipsilateral cage and screws. Cage size and location seemingly the main reasons with advice to use large cage and cage insertion in oblique fashion to cross the midline. This study was designed to solve these issues. Sample size: The Study will include 40 patients divided into two groups, each group containing 20 patients.

Official Title
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A Novel Technique for Degenerative Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage Fusion

Conditions
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Treatment

Intervention / Treatment
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* Procedure: pedicle screw fixation on one side and intervertebral cage on the other sided
* Procedure: pedicle screw fixation and interbody cage on the same side


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient acceptance. Both sexes. Age (21-60) years old. Patients with monosegmental lumber degenerative spinal diseases including lumbar spondylosis, spondylolysis, spondylolisthesis grade one, or lumbar disc prolapse. Exclusion Criteria: Patient refusal. Altered mental status. Patients with associated comorbidity interfere with surgery. Extremes of age. Multiple level lumbar degenerative disease Trauma Spinal tumour Active infection Previous lumbar operation

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>pedicle screw fixation on one side and intervertebral cage on the other sided | Procedure: pedicle screw fixation on one side and intervertebral cage on the other sided<br>* pedicle screw fixation on one side and intervertebral cage on the other sided<br>|
| Active Comparator: Group B<br>pedicle screw fixation and interbody cage on the same side | Procedure: pedicle screw fixation and interbody cage on the same side<br>* pedicle screw fixation and interbody cage on the same side<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of fusion status | Evaluation of fusion status using CT scan and Xray | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back Pain | use of Visual Analogue Scale (VAS) as a 10-cm line labeled with (0= no pain and 10=worst pain) | At 24 hours, 2 weeks and 3 months after surgery |