NCT07294417 Bone Cement Augmented Transpedicular Screw Fixation Versus Cannulated Screws Fixation in Osteoporotic Spine
| NCT ID | NCT07294417 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kafrelsheikh University |
| Condition | Bone Cement Augmented Transpedicular Screw Fixation |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-12-20 |
| Primary Completion | 2026-06-01 |
Trial Parameters
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Brief 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 Criteria
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.