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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Cement Augmented Transpedicular Screw Fixation; Cannulated Screws Fixation; Osteoporotic Spine
• Intervention / Treatment: Procedure: Bone Cement Augmented Transpedicular Screw Fixation; Procedure: Cannulated Screws Fixation

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed A Zahra, MD; Phone Number: 00201004642184; Email: a86anas@gmail.com

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Recruiting
      • Kafrelsheikh University
      • Contact: Ahmed A Zahra, MD; Phone Number: 00201004642184; Email: a86anas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients will be treated with bone cement augmented transpedicular screw fixation.	Procedure: Bone Cement Augmented Transpedicular Screw Fixation; Patients will be treated with bone cement augmented transpedicular screw fixation.
Active Comparator: Group B; Patients will be treated with cannulated pedicle screw fixation.	Procedure: Cannulated Screws Fixation; Patients will be treated with cannulated pedicle screw fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of wound infection	Incidence of wound infection will be recorded.	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complication rates	Incidence of complication rates will be recorded.	6 months post-procedure

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: December 6, 2025
• First Posted (Estimated): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: KFSIRB200-824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No