Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-08-31

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.

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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.

Conditions

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Fusion of Spine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 (Unilateral Pedicle Screw Fixation)

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.

Group Type EXPERIMENTAL

Unilateral Pedicle Screw Fixation

Intervention Type PROCEDURE

Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod

Group 2 (Bilateral Pedicle Screw Fixation)

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.

Group Type ACTIVE_COMPARATOR

Bilateral Pedicle Screw Fixation

Intervention Type PROCEDURE

Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods

Interventions

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Unilateral Pedicle Screw Fixation

Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod

Intervention Type PROCEDURE

Bilateral Pedicle Screw Fixation

Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No