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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Unilateral Pedicle Screw Fixation) | Experimental | 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. |
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| Group 2 (Bilateral Pedicle Screw Fixation) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unilateral Pedicle Screw Fixation | Procedure | Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vadim Cherepanov, MD, PhD | Contact | +79166548850 | cvg_cherepanov@mail.ru | |
| Ivan Vyazankin, MD | Contact | +79163770457 | vzvzvzvan@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Alexey Lychagin, MD, PhD | IM Sechenov University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sechenov University | Recruiting | Moscow | 119991 | Russia |
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| Bilateral Pedicle Screw Fixation | Procedure | Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods |
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