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Comparative study of lumbar spine stabilization with 2-stage surgery and cement augmentation

A comparative study of lumbar spine stabilization with 2-stage surgery and cement augmentation in osteoporosis patients: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230222057496N3
Enrollment
66
Registered
2024-02-26
Start date
2022-11-22
Completion date
Unknown
Last updated
2024-03-06

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

Conditions

Lumbar spine degeneration. Other degenerative diseases of the nervous system

Interventions

Intervention 1: Intervention group first
First intervention group: Lumbar spine stabilization surgery in one step along with pedicle screw reinforcement with bone cement. Intervention 2: Intervention group second: Spine stabilization surgery

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: Osteoporosis patients with pre-surgery bone density in the range (T-Score->2.5) age range over 50 years body mass index between 20-30 with degenerative lumbar spine complications at L1-S1 level is

Exclusion criteria

Exclusion criteria: Patients who could not be reached or lived outside the province pationts did not want to enter the study The presence of other pathological factors (cysts or tumors) discopathy in other vertebrae performing any re-surgery during the past year using narcotics or narcotic drugs and smoking suffering from underlying diseases affecting Osteoporosis (rheumatoid arthritis, thyroid disorders...)

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Before surgery - one month after surgery. Method of measurement: VAS visual analog scale.;Disability of patients. Timepoint: Before surgery - one month after surgery. Method of measurement: Oswestry Disability Index (ODI).

Secondary

MeasureTime frame
Fution. Timepoint: 12 months after surgery. Method of measurement: BSF classification scale.;Pedicle Screw loosing. Timepoint: 12 months after surgery. Method of measurement: Dynamic radiography and CT scan images.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa hajilo

Hamedan University of Medical Sciences

Parisahajilo73@gmail.com+98 81 3131 0000

Outcome results

None listed

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