Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

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.

Study Overview

• Status: Unknown
• Conditions: Fusion of Spine
• Intervention / Treatment: Procedure: Unilateral Pedicle Screw Fixation; Procedure: Bilateral Pedicle Screw Fixation

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Sechenov University
    • Contact: Vadim Cherepanov, professor; Phone Number: +79166548850; Email: cvg_cherepanov@mail.ru
    • Contact: Ivan Vyazankin; Phone Number: +79163770457; Email: vzvzvzvan@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Unilateral Pedicle Screw Fixation; Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod
Active Comparator: 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.	Procedure: Bilateral Pedicle Screw Fixation; Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Study Chair: Alexey Lychagin, MD, Phd, IM Sechenov University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: May 23, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: degenerative spine; unilateral fixation of the spine; fusion of the lumbar spine; posterior stabilization
• Other Study ID Numbers: 1123 (WRAIR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No