Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

I

I.M. Sechenov First Moscow State Medical University

Status

Unknown

Conditions

Fusion of Spine

Treatments

Procedure: Unilateral Pedicle Screw Fixation
Procedure: Bilateral Pedicle Screw Fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT04415814
1123

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Group 1 (Unilateral Pedicle Screw Fixation)
Experimental group
Description:
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.
Treatment:
Procedure: Unilateral Pedicle Screw Fixation
Group 2 (Bilateral Pedicle Screw Fixation)
Active Comparator group
Description:
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.
Treatment:
Procedure: Bilateral Pedicle Screw Fixation

Trial contacts and locations

1

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Central trial contact

Ivan Vyazankin, MD; Vadim Cherepanov, MD, PhD

Data sourced from clinicaltrials.gov

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