Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    I.M. Sechenov First Moscow State Medical University
Updated on 19 February 2024

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.

Details
Condition Fusion of Spine
Age 18-90 years
Treatment Unilateral Pedicle Screw Fixation, Bilateral Pedicle Screw Fixation
Clinical Study IdentifierNCT04415814
SponsorI.M. Sechenov First Moscow State Medical University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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