Bone Cement Augmented Transpedicular Screw Fixation Versus Cannulated Screws Fixation in Osteoporotic Spine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bone Cement Augmented Transpedicular Screw Fixation, Cannulated Screws Fixation.
- Who it may be relevant to
- Registry conditions: Bone Cement Augmented Transpedicular Screw Fixation, Cannulated Screws Fixation, Osteoporotic Spine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Bone Cement Augmented Transpedicular Screw Fixation
Patients will be treated with bone cement augmented transpedicular screw fixation. - Procedure Cannulated Screws Fixation
Patients will be treated with cannulated pedicle screw fixation.
Primary outcome measures
- Incidence of wound infection [Time frame: 6 months post-procedure]
Secondary outcome measures (1)
- Incidence of complication rates [Time frame: 6 months post-procedure]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Kafrelsheikh University — Kafr ash Shaykh
Identifiers
NCT: NCT07294417 · KFSIRB200-824