Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

Study Overview
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Brief Summary
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Determining the treatment strategy for patients with degenerative diseases of the spine is extremely difficult, without an accurate understanding of the nature of stress distribution in the vertebral-motor segments of the spine, as well as biomechanical changes that are associated with degenerative diseases of the spine. In this clinical study, we want to compare the use of unilateral and bilateral transpedicular fixation for treating the patients with degenerative diseases of the lumbar spine.

Detailed Description
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It is planned to use posterior stabilization without interbody fusion. In the postoperative period, all the patients receive antibacterial and analgesic therapy. The early postoperative period is spent in a hospital. Repeated appearances for control examinations (3, 6, 12 months) are provided for physical examination (EQ-5D, Oswestry Disability Index) and performing radiographs or computed tomography (CT) of the spine. All patients undergo a standard rehabilitation course.

Official Title
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Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

Conditions
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Fusion of Spine

Intervention / Treatment
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* Procedure: Unilateral Pedicle Screw Fixation
* Procedure: Bilateral Pedicle Screw Fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent of the patient to participate in the study; Patients with degenerative diseases of the lumbar spine. The opportunity for observation during the entire study period (12 months); Mental adequacy, ability, willingness to cooperate and follow the doctor's recommendations. Exclusion Criteria: The refusal of a patient from surgery The presence of contraindications to surgery Severe forms of diabetes (glycosylated hemoglobin >9%); Blood diseases (thrombopenia, thrombocytopenia, anemia with Hb< 90g\l); The unwillingness of the patient to conscious cooperation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Group 1 (Unilateral Pedicle Screw Fixation)<br>Patients will undergo stabilizing surgery on the lumbar spine for degenerative diseases of the spine. Pedicular screws will be installed unilaterally, which means on one side of the spinous processes. The system will be fixed with standard rod and blockers. | Procedure: Unilateral Pedicle Screw Fixation<br>* Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod<br>|
| Active Comparator: Group 2 (Bilateral Pedicle Screw Fixation)<br>Patients will undergo stabilizing surgery on the lumbar spine for degenerative diseases of the spine. Pedicular screws will be installed bilaterally, which means on the both sides of the spinous processes. The system will be fixed with standard rods and blockers. | Procedure: Bilateral Pedicle Screw Fixation<br>* Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fusion rate of the operated spine segment | Control CT/Radiography examination | in 3 months after surgery | 
| fusion rate of the operated spine segment | Control CT/Radiography examination | in 6 months after surgery | 
| fusion rate of the operated spine segment | Control CT/Radiography examination | in 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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degenerative spine, unilateral fixation of the spine, fusion of the lumbar spine, posterior stabilization