Bone Cement Augmented Transpedicular Screw Fixation, Cannulated Screws Fixation, Osteoporotic Spine
Conditions
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.
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.
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.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of wound infection | 6 months post-procedure | Incidence of wound infection will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complication rates | 6 months post-procedure | Incidence of complication rates will be recorded. |
Countries
Egypt
Contacts
Primary ContactAhmed A Zahra, MD
Outcome results
None listed