Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

Fusion of Spine Clinical Trial

Official title:

Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04415814
• Other study ID #: 1123
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2020
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Vadim Cherepanov, MD, PhD
• Phone: +79166548850
• Email: cvg_cherepanov[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fusion of Spine

Intervention

Procedure:
• Unilateral Pedicle Screw Fixation
Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod
• Bilateral Pedicle Screw Fixation
Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods

Locations

Country	Name	City	State
Russian Federation	Sechenov University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fusion rate of the operated spine segment	Control CT/Radiography examination	in 3 months after surgery
Primary	fusion rate of the operated spine segment	Control CT/Radiography examination	in 6 months after surgery
Primary	fusion rate of the operated spine segment	Control CT/Radiography examination	in 12 months after surgery