RecruitingNot ApplicableNCT07294417

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


Sponsor

Kafrelsheikh University

Enrollment

70 participants

Start Date

Dec 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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.

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Interventions

PROCEDUREBone Cement Augmented Transpedicular Screw Fixation

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

PROCEDURECannulated Screws Fixation

Patients will be treated with cannulated pedicle screw fixation.


Locations(1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

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NCT07294417