Comparison of cranial and caudal pedicle screw-selective unilateral cemented versus fully reinforced pedicle screws in the lumbar spine

Comparison of cranial and caudal pedicle screw-selective unilateral cemented versus fully reinforced pedicle screws in the lumbar spine of patients with osteoporosis a prospective randomized clinical trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057496N6

Enrollment

Registered

2025-09-25

Start date

2025-10-22

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative disease of the lumbar spine. Other degenerative disorders of nervous system in diseases classified elsewhere

Interventions

Intervention 1: Intervention group: Pedicle Screw Fixation + Cement: Initially, a midline incision was made in the posterior region, and then a decompression procedure including bilateral partial face

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 50 years T-score < - 2.5 BMI between 30-20 The patient is free of uncontrolled chronic diseases such as diabetes or cardiovascular disorders.

Exclusion criteria

Exclusion criteria: Previous surgery in the lumbar region Degenerative disorders in other vertebrae Taking opioids to relieve pain Unwillingness to follow up after surgery

Design outcomes

Primary

Measure	Time frame
Bleeding. Timepoint: During surgery. Method of measurement: Blood, suction bottle and blood gases.;Time Surgery. Timepoint: During Surgery. Method of measurement: Smartwatch.;Pain. Timepoint: Before surgery and in the first month after surgery. Method of measurement: Visual analog scale.;Infection. Timepoint: After surgery. Method of measurement: Southampton Scale.;Functional Disability. Timepoint: Before surgery and in the first month after surgery. Method of measurement: Functional Disability Questionnaire.	—

Measure

Time frame

Bleeding. Timepoint: During surgery. Method of measurement: Blood, suction bottle and blood gases.;Time Surgery. Timepoint: During Surgery. Method of measurement: Smartwatch.;Pain. Timepoint: Before surgery and in the first month after surgery. Method of measurement: Visual analog scale.;Infection. Timepoint: After surgery. Method of measurement: Southampton Scale.;Functional Disability. Timepoint: Before surgery and in the first month after surgery. Method of measurement: Functional Disability Questionnaire.

—

Secondary

Measure	Time frame
Pain. Timepoint: 12th month after surgery. Method of measurement: Visual analog scale.;Functional Disability. Timepoint: 12th month after surgery. Method of measurement: Functional Disability Questionnaire.;Fution. Timepoint: 12th month after surgery. Method of measurement: Radiographic image.;Loosening of the screw. Timepoint: 12th month after surgery. Method of measurement: Radiographic image.;Adjacent segment damage. Timepoint: 12th month after surgery. Method of measurement: Radiographic image.	—

Measure

Time frame

Pain. Timepoint: 12th month after surgery. Method of measurement: Visual analog scale.;Functional Disability. Timepoint: 12th month after surgery. Method of measurement: Functional Disability Questionnaire.;Fution. Timepoint: 12th month after surgery. Method of measurement: Radiographic image.;Loosening of the screw. Timepoint: 12th month after surgery. Method of measurement: Radiographic image.;Adjacent segment damage. Timepoint: 12th month after surgery. Method of measurement: Radiographic image.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Mehrafshan

Ghoum University of Medical Sciences

Alimehrafshan2@gmail.com+98 25 3861 9252

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026