Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

I.M. Sechenov First Moscow State Medical University

Status: Unknown

Conditions: Fusion of Spine

Treatments: Procedure: Unilateral Pedicle Screw Fixation; Procedure: Bilateral Pedicle Screw Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT04415814

1123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group 1 (Unilateral Pedicle Screw Fixation)

Experimental group

Description:

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.

Treatment:

Procedure: Unilateral Pedicle Screw Fixation

Group 2 (Bilateral Pedicle Screw Fixation)

Active Comparator group

Description:

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.

Treatment:

Procedure: Bilateral Pedicle Screw Fixation