Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

Not Applicable

• Conditions: Fusion of Spine
• Interventions: Procedure: Unilateral Pedicle Screw Fixation; Procedure: Bilateral Pedicle Screw Fixation

• Registration Number: NCT04415814
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-04
• Study First Submitted: 2020-05-23
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-04
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-25
• Primary Completion: 2021-06-30
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Unilateral Pedicle Screw Fixation)	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 2 (Bilateral Pedicle Screw Fixation)	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.

Primary Outcome Measures

Name	Time	Method
fusion rate of the operated spine segment	in 12 months after surgery	Control CT/Radiography examination

Trial Locations

Locations (1)

Sechenov University; 🇷🇺 Moscow, Russian Federation