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Bone Cement Augmented Transpedicular Screw Fixation Versus Cannulated Screws Fixation in Osteoporotic Spine

NCT ID: NCT07294417

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-20

Study Completion Date

2026-06-01

Brief Summary

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This study aims to compare the clinical and radiological outcomes of bone-cement-augmented transpedicular screw fixation versus cannulated pedicle screw fixation in patients with osteoporotic spines requiring posterior instrumentation, with respect to implant stability (loosening/pull-out), pain relief, functional recovery, and complication rates.

Detailed Description

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Osteoporosis of the spine presents a significant challenge in spine surgery, particularly when instrumentation is needed for stabilization. With declining bone mineral density, conventional pedicle screw purchase becomes unreliable, leading to increased rates of screw loosening, pull-out, and fixation failure.

A relevant development in instrumentation has been the use of cannulated pedicle screws, sometimes in combination with cement-injectable systems, designed to allow cement to flow through the screw to reinforce fixation. Such systems have shown improved implant stability and lower failure rates in osteoporotic bone compared with solid screws.

Conditions

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Bone Cement Augmented Transpedicular Screw Fixation Cannulated Screws Fixation Osteoporotic Spine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Patients will be treated with bone cement augmented transpedicular screw fixation.

Group Type EXPERIMENTAL

Bone Cement Augmented Transpedicular Screw Fixation

Intervention Type PROCEDURE

Patients will be treated with bone cement augmented transpedicular screw fixation.

Group B

Patients will be treated with cannulated pedicle screw fixation.

Group Type ACTIVE_COMPARATOR

Cannulated Screws Fixation

Intervention Type PROCEDURE

Patients will be treated with cannulated pedicle screw fixation.

Interventions

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Bone Cement Augmented Transpedicular Screw Fixation

Patients will be treated with bone cement augmented transpedicular screw fixation.

Intervention Type PROCEDURE

Cannulated Screws Fixation

Patients will be treated with cannulated pedicle screw fixation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years old.
* Both sexes.
* Patients with confirmed osteoporosis on dual-energy X-ray absorptiometry (DEXA) scan (T-score ≤ -2.5),
* Patients presented with painful osteoporotic vertebral fractures, degenerative instability, or traumatic compression fractures.
* Patients are unresponsive to conservative management and require surgical stabilization.

Exclusion Criteria

* Patients with healed or stable fractures respond to medical treatment.
* Patients with uncontrolled coagulopathy, active spinal infections such as discitis or osteomyelitis.
* Patients with spinal deformity exceeding thirty degrees, or vertebral body collapse greater than seventy percent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Anas Zahra

Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed A Zahra, MD

Role: CONTACT

Phone: 00201004642184

Email: [email protected]

Facility Contacts

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Ahmed A Zahra, MD

Role: primary

Other Identifiers

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KFSIRB200-824

Identifier Type: -

Identifier Source: org_study_id