Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

Sponsor

I.M. Sechenov First Moscow State Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04415814

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fusion of Spine	Procedure: Unilateral Pedicle Screw Fixation Procedure: Bilateral Pedicle Screw Fixation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

fusion rate of the operated spine segment [in 3 months after surgery]
Control CT/Radiography examination
fusion rate of the operated spine segment [in 6 months after surgery]
Control CT/Radiography examination
fusion rate of the operated spine segment [in 12 months after surgery]
Control CT/Radiography examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sechenov University	Moscow		Russian Federation	119991

Sponsors and Collaborators

I.M. Sechenov First Moscow State Medical University

Investigators

Study Chair: Alexey Lychagin, MD, PhD, IM Sechenov University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

I.M. Sechenov First Moscow State Medical University

ClinicalTrials.gov Identifier:

NCT04415814

Other Study ID Numbers:

1123

First Posted:

Jun 4, 2020

Last Update Posted:

Sep 25, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by I.M. Sechenov First Moscow State Medical University

degenerative spine

unilateral fixation of the spine

fusion of the lumbar spine

posterior stabilization

Study Results

No Results Posted as of Sep 25, 2020