Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07294417

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
Kafrelsheikh University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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

Interventions

TypeNameDescription
PROCEDUREBone Cement Augmented Transpedicular Screw FixationPatients will be treated with bone cement augmented transpedicular screw fixation.
PROCEDURECannulated Screws FixationPatients will be treated with cannulated pedicle screw fixation.

Timeline

Start date
2025-12-20
Primary completion
2026-06-01
Completion
2026-06-01
First posted
2025-12-19
Last updated
2025-12-23

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07294417. Inclusion in this directory is not an endorsement.