Bone Cement Augmented Transpedicular Screw FixationNCT07294417
Bone Cement Augmented Transpedicular Screw Fixation Versus Cannulated Screws Fixation in Osteoporotic Spine
A study testing Bone Cement Augmented Transpedicular Screw Fixation and Cannulated Screws Fixation in people with Bone Cement Augmented Transpedicular Screw Fixation and Cannulated Screws Fixation, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Cement Augmented Transpedicular Screw Fixation, Cannulated Screws Fixation, Osteoporotic Spine
- What is being tested?
- Bone Cement Augmented Transpedicular Screw Fixation and Cannulated Screws Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 33516
Ahmed A Zahra, MD, 00201004642184, a86anas@gmail.com
About this study
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.
Read the 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
- Bone Cement Augmented Transpedicular Screw Fixation, Cannulated Screws Fixation, Osteoporotic Spine
- Being tested
- Bone Cement Augmented Transpedicular Screw Fixation, Cannulated Screws Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Cement Augmented Transpedicular Screw FixationProcedure or surgery
Patients will be treated with bone cement augmented transpedicular screw fixation.
Cannulated Screws FixationProcedure or surgery
Patients will be treated with cannulated pedicle screw fixation.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will be treated with bone cement augmented transpedicular screw fixation. Receives: Procedure: Bone Cement Augmented Transpedicular Screw Fixation |
| Group B | Active comparator | Patients will be treated with cannulated pedicle screw fixation. Receives: Procedure: Cannulated Screws Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound infection
Incidence of wound infection will be recorded.
Measured: 6 months post-procedure
Secondary outcomes (1)
Incidence of complication rates
Incidence of complication rates will be recorded.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start20 Dec 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Cement Augmented Transpedicular Screw FixationStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Anas Zahra, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294417
- Sponsor's protocol ID
- KFSIRB200-824
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Cement Augmented Transpedicular Screw Fixation Versus Cannulated Screws Fixation in Osteoporotic Spine
- ClinicalTrials.gov ID
- NCT07294417
- Acronym / sponsor ID
- KFSIRB200-824
- Conditions
- Bone Cement Augmented Transpedicular Screw Fixation, Cannulated Screws Fixation, Osteoporotic Spine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Bone Cement Augmented Transpedicular Screw FixationPatients will be treated with bone cement augmented transpedicular screw fixation. |
| Group B | Active comparator | Procedure: Cannulated Screws FixationPatients will be treated with cannulated pedicle screw fixation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Cement Augmented Transpedicular Screw FixationPatients will be treated with bone cement augmented transpedicular screw fixation. | Procedure or surgery | Group A |
| Cannulated Screws FixationPatients will be treated with cannulated pedicle screw fixation. | Procedure or surgery | Group B |
Primary outcome
Incidence of wound infection
Time frame: 6 months post-procedure
Incidence of wound infection will be recorded.
1 secondary outcome
Incidence of complication rates
Time frame: 6 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Cement Augmented Transpedicular Screw Fixation and Cannulated Screws Fixation in people with Bone Cement Augmented Transpedicular Screw Fixation and Cannulated Screws Fixation, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Zahra, MD (00201004642184, a86anas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of wound infection (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.