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

Kafrelsheikh University

Status: Enrolling

Conditions: Osteoporotic Spine; Bone Cement Augmented Transpedicular Screw Fixation; Cannulated Screws Fixation

Treatments: Procedure: Bone Cement Augmented Transpedicular Screw Fixation; Procedure: Cannulated Screws Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT07294417

KFSIRB200-824

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Group A

Experimental group

Description:

Patients will be treated with bone cement augmented transpedicular screw fixation.

Treatment:

Procedure: Bone Cement Augmented Transpedicular Screw Fixation

Group B

Active Comparator group

Description:

Patients will be treated with cannulated pedicle screw fixation.

Treatment:

Procedure: Cannulated Screws Fixation