Fusion of Spine
Conditions
Keywords
degenerative spine, unilateral fixation of the spine, fusion of the lumbar spine, posterior stabilization
Brief summary
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
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.
Interventions
PROCEDUREUnilateral Pedicle Screw Fixation
Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod
PROCEDUREBilateral Pedicle Screw Fixation
Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fusion rate of the operated spine segment | in 3 months after surgery | Control CT/Radiography examination |
Countries
Russia
Contacts
Primary ContactVadim Cherepanov, MD, PhD
Backup ContactIvan Vyazankin, MD
Outcome results
None listed