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NCT Number: NCT07294417

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location status: Recruiting

Location contact

Ahmed A Zahra, MD

CONTACT

[email protected]

00201004642184

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bone Cement Augmented Transpedicular Screw Fixation

Procedure

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

Cannulated Screws Fixation

Procedure

Patients will be treated with cannulated pedicle screw fixation.

Primary outcomes

  1. Incidence of wound infection

    Time frame: 6 months post-procedure

    Incidence of wound infection will be recorded.

Secondary outcomes

  1. Incidence of complication rates

    Time frame: 6 months post-procedure

    Incidence of complication rates will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Zahra, MD

CONTACT

[email protected]

00201004642184

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.