NCT04415814

Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fusion of Spine

Interventions

Type	Name	Description
PROCEDURE	Unilateral Pedicle Screw Fixation	Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod
PROCEDURE	Bilateral Pedicle Screw Fixation	Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-06-30
• Completion: 2022-08-31
• First posted: 2020-06-04
• Last updated: 2020-09-25

Locations

1 site across 1 country: Russia