Bone cement-augmented versus cannulated pedicle screw fixation for osteoporotic spines
Official title: Bone Cement Augmented Transpedicular Screw Fixation Versus Cannulated Screws Fixation in Osteoporotic Spine
Run by Kafrelsheikh University · NCT07294417 · Data updated 2026-11-12
This study will test whether bone cement‑augmented transpedicular screws or cannulated pedicle screws give adults with osteoporotic spines stronger fixation, less pain, and better function after surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr ash Shaykh, Kafrelsheikh) |
| Status | Recruiting |
| Started | December 20, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07294417 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18 years) with DEXA-confirmed osteoporosis (T-score ≤ -2.5) who have painful osteoporotic vertebral fractures, degenerative instability, or traumatic compression fractures that have not improved with conservative treatment and require surgical posterior stabilization.
✕Probably not a fit
Patients unlikely to benefit include those with healed or stable fractures responsive to medical treatment, active spinal infection or uncontrolled coagulopathy, severe spinal deformity (>30 degrees) or vertebral body collapse >70%, or those who do not require operative stabilization.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional comparison enrolls adults with DEXA-confirmed osteoporosis who require posterior spinal instrumentation for painful osteoporotic fractures, degenerative instability, or traumatic compression fractures unresponsive to conservative care. Participants will receive posterior fixation using either bone cement‑augmented transpedicular screws or cannulated pedicle screws and will be followed clinically and radiologically. Primary outcomes include implant stability (loosening and pull‑out), pain relief, and functional recovery, with secondary monitoring of complication rates and radiographic measures. Surgical technique, perioperative care, and follow‑up imaging will be used to compare mechanical performance and patient-centered outcomes between the two fixation methods.
Why it matters
Potential benefit: If successful, the approach could reduce screw loosening and fixation failures, resulting in more durable spinal stabilization, less pain, and faster recovery for patients with osteoporotic spines.
How similar studies have gone: Previous studies of cement augmentation and cement‑injectable cannulated screw systems have shown improved implant stability and lower failure rates in osteoporotic bone, but direct head-to-head comparative data are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, Egypt Recruiting
Study contacts
- Study coordinator: Ahmed A Zahra, MD
- Email: a86anas@gmail.com
- Phone: 00201004642184
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.