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Comparison of clinical and radiological outcomes between two methods of using cortical screws and pedicle screws in multilevel lumbar spine fusion surgery

Comparison of clinical and radiological outcomes between two methods of using cortical screws and pedicle screws in multilevel lumbar spine fusion surgery at Imam Khomeini Hospital, Tehran

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251010067572N1
Enrollment
102
Registered
2025-11-05
Start date
2025-09-29
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Multilevel lumbar spine fusion surgery. Spinal stenosis

Interventions

Intervention 1: Intervention group: In the pedicle screws group, the entry site will be at the apex of the herringbone crest and the junction of the transverse process with the lateral edge of the sup

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Male and female patients 18 years of age and older Patients with low back disease who are candidates for two- to four-level fusion surgery and whose symptoms include radiculopathy and/or nerve palsy, with or without back pain. Patients who have not responded to conservative treatment (medication and physical therapy) for at least 3 months or who have shown progressive neurological symptoms during this treatment. Patients who are willing to sign a research consent and follow-up for at least 1 year.

Exclusion criteria

Exclusion criteria: Patients with a T-Score greater than -2.5 in BMD (osteoporosis) Patients with involvement of less than two lumbar spine levels or more than four levels History of lumbar fusion surgery or active local/systemic infection or fracture Pregnant patients Inability to adhere to the 1-year follow-up schedule Use of glucocorticoids or immunosuppressive drugs Spondylolisthesis with Myroding grade = III or IV

Design outcomes

Primary

MeasureTime frame
The patient's degree of functional disability in daily activities. Timepoint: At intervals before surgery/at discharge/one month after surgery/three months after surgery/one year after surgery. Method of measurement: ODI questionnaire.

Secondary

MeasureTime frame
Facet joint injury rate. Timepoint: After surgery. Method of measurement: CT scan.;Screw placement accuracy. Timepoint: After surgery. Method of measurement: CT scan.;Fusion rate. Timepoint: At three and twelve months after surgery. Method of measurement: Ct scan.;Loosening of screws. Timepoint: At three and twelve months after surgery. Method of measurement: Ct scan.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Doustkani

Tehran University of Medical Sciences

mohammad.doustkani@gmail.com+98 21 6119 5920

Outcome results

None listed

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