Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

NCT04415814 | Unknown DMC

• 1 other identifier: 1123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fusion of Spine

Keywords

degenerative spine; unilateral fixation of the spine; fusion of the lumbar spine; posterior stabilization

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group 1 (Unilateral Pedicle Screw Fixation)

EXPERIMENTAL

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

Group 2 (Bilateral Pedicle Screw Fixation)

ACTIVE COMPARATOR

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

Interventions

Unilateral Pedicle Screw Fixation PROCEDURE

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

Group 1 (Unilateral Pedicle Screw Fixation)

Bilateral Pedicle Screw Fixation PROCEDURE

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

Group 2 (Bilateral Pedicle Screw Fixation)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Sechenov University

Moscow, 119991, Russia

RECRUITING

Study Officials

• Alexey Lychagin, MD, PhD

  IM Sechenov University

  STUDY CHAIR

Central Study Contacts

Vadim Cherepanov, MD, PhD

CONTACT

+79166548850; cvg_cherepanov@mail.ru

Ivan Vyazankin, MD

CONTACT

+79163770457; vzvzvzvan@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: June 4, 2020
• Study Start: January 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2022
• Last Updated: September 25, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)