Lumbar SpondylolisthesisNCT03327298
Free Hand Lumbar Pedicular Screw Fixation
A study testing pedicle screw fixation in people with Lumbar Spondylolisthesis, run by Zagazig University.
Trial summary
Background: Different methods for lumbar pedicular screw insertion have been advocated, however each technique has its cons and pros. Due to limited resources for O-Arm and navigation in our locality, the investigator was enforced to use the surgical skills to minimize the need for such advanced modalities. Read more about this study
- Who is it for?
- Ages 24 to 73 years
- Conditions the study is for
- Lumbar Spondylolisthesis
- What is being tested?
- pedicle screw fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2014to 5 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single level or double level degenerative spondylolisthesis
Who cannot join
- other causes of spondylolisthesis
About this study
Official title: Direct Pedicle Visualization And Disc Space Orientation As The Only Guide For Lumbar Pedicular Screw Insertion
Background: Different methods for lumbar pedicular screw insertion have been advocated, however each technique has its cons and pros. Due to limited resources for O-Arm and navigation in our locality, the investigator was enforced to use the surgical skills to minimize the need for such advanced modalities.
Aim of the study: Is to clarify the benefits of the use of free hand technique using direct visualization of the pedicles and disc space as the only guide for pedicular screw insertion using postoperative CT for evaluation of the accuracy of pedicle screw insertion.
Patients and methods: One hundred and forty four screws were inserted in 32 patients using direct pedicle visualization and disc space orientation as a single intraoperative reference guide. The study was conducted in Zagazig University Hospitals from May, 2014 to June, 2015. CT was done for all patients as a direct postoperative evaluation tool.
Read the detailed description
Patients and methods: This study was conducted in Zagazig University Hospitals in the period from May 2014 to June 2015 after approval from the Zagazig University Institutional Review Board (Zu-IRB). All patients were subjected to complete history talking, clinical evaluation and adequate radiological and laboratory investigations.
The radiological studies included plain X-Ray lumbosacral spine, anteroposterior, lateral neutral, and lateral dynamic views (lateral with flexion and lateral with extension), MRI lumbosacral spine sagittal and axial views, and in some cases CT lumbosacral spine with sagittal reconstruction. All these modalities give us a good idea about both soft tissue and bony pathology in the area of interest. Selection of the patients for surgery was based on clinicoradiologic items.
All the cases of pedicular screw insertion were preceded by full laminectomy with discectomy for interbody fusion. In all cases the medial and inferior aspects of the pedicle are clearly visualized, so selection of the entry point and direct observation of medial and inferior pedicle violation are two main advantages of this technique. On the other hand after discectomy the disc space with the two parallel endplates are available for use as a guide for screw craniocaudal angulation.
After the removal of the whole lamina with its inferior articular processes and removal of fibrocartilagenous tissues overlying the exiting roots and removal of the intervertebral disc, the anatomy of the pedicle and its relation to the exiting roots is clearly evident.
Starting pedicular screw insertion, part of the cortical bone at the inferolateral edge of the superior facet is removed. This entry point lies exactly along the transverse plane passing through the middle of the corresponding transverse process.
At the same time the inferior and medial surfaces of the pedicle along with the exiting nerve root are clearly visualized, so all factors needed for correct pedicle screw insertion are available including the correct entry point, the mediolateral and craniocaudal orientation in addition to the visual protection provided from inside the canal to observe any medial or inferior pedicle violation.
The investigator used to insert a dissector inside the disc space as an additional guide to craniocaudal orientation of the screw which should be parallel to the disc space.
The process of pedicular screw insertion is completed as usual and the disc space is properly curetted using the suitable shavers then the prepared autologous bone graft is impacted in the disc space. The remaining screws are inserted and the rods are installed and secured as usual.
The time needed for each screw insertion was calculated. During the previous steps neither fluoroscopic guidance nor neuronavigation were used.
After completion of the previous steps, a single lateral and anteroposterior film was used to confirm the correct screw position.
The surgery is completed as usual and the patient is discharged for follow up after two weeks, during which a complementary CT scan lumbar spine is routinely performed and analyzed for the accuracy of the screw position.
Pedicle violation was assessed whether medial, inferior, lateral or superior.
- Conditions
- Lumbar Spondylolisthesis
- Being tested
- pedicle screw fixation
- Keywords
- Pedicle screw. Free hand. Lumbar fixation
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedicle screw fixationProcedure or surgery
One hundred forty four screws were placed in the lumbosacral pedicles of 32 patients using free hand technique depending on direct visualization of the pedicles, roots, and intervertebral disc ( IVD) after doing full laminectomy, then postoperative CT was done for evaluation of pedicle violation.
| Study group | Role | What they receive |
|---|---|---|
| accuracy of pedicle screw insertion | Other | postoperative CT lumbar spine axial and sagittal views. Receives: Procedure: pedicle screw fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pedicle screw accuracy
Pedicle violation was assessed whether medial, inferior, lateral or superior using postoperative CT
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start10 May 2014
- Primary completion5 Jun 2015
- Study completion5 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hosni Salama, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327298
- Sponsor's protocol ID
- ZU-IRB#3925-24-3-2014
- Status last verified
- Oct 2017
- First submitted
- 17 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Pedicle Visualization And Disc Space Orientation As The Only Guide For Lumbar Pedicular Screw Insertion
- ClinicalTrials.gov ID
- NCT03327298
- Acronym / sponsor ID
- ZU-IRB#3925-24-3-2014
- Conditions
- Lumbar Spondylolisthesis
- Keywords
- Pedicle screw. Free hand. Lumbar fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 May 2014 (actual)
- Primary completion
- 5 Jun 2015 (actual)
- Study completion
- 5 Jun 2015 (actual)
- First posted
- 31 Oct 2017 (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.
Background: Different methods for lumbar pedicular screw insertion have been advocated, however each technique has its cons and pros. Due to limited resources for O-Arm and navigation in our locality, the investigator was enforced to use the surgical skills to minimize the need for such advanced modalities.
Aim of the study: Is to clarify the benefits of the use of free hand technique using direct visualization of the pedicles and disc space as the only guide for pedicular screw insertion using postoperative CT for evaluation of the accuracy of pedicle screw insertion.
Patients and methods: One hundred and forty four screws were inserted in 32 patients using direct pedicle visualization and disc space orientation as a single intraoperative reference guide. The study was conducted in Zagazig University Hospitals from May, 2014 to June, 2015. CT was done for all patients as a direct postoperative evaluation tool.
Detailed description
Patients and methods: This study was conducted in Zagazig University Hospitals in the period from May 2014 to June 2015 after approval from the Zagazig University Institutional Review Board (Zu-IRB). All patients were subjected to complete history talking, clinical evaluation and adequate radiological and laboratory investigations.
The radiological studies included plain X-Ray lumbosacral spine, anteroposterior, lateral neutral, and lateral dynamic views (lateral with flexion and lateral with extension), MRI lumbosacral spine sagittal and axial views, and in some cases CT lumbosacral spine with sagittal reconstruction. All these modalities give us a good idea about both soft tissue and bony pathology in the area of interest. Selection of the patients for surgery was based on clinicoradiologic items.
All the cases of pedicular screw insertion were preceded by full laminectomy with discectomy for interbody fusion. In all cases the medial and inferior aspects of the pedicle are clearly visualized, so selection of the entry point and direct observation of medial and inferior pedicle violation are two main advantages of this technique. On the other hand after discectomy the disc space with the two parallel endplates are available for use as a guide for screw craniocaudal angulation.
After the removal of the whole lamina with its inferior articular processes and removal of fibrocartilagenous tissues overlying the exiting roots and removal of the intervertebral disc, the anatomy of the pedicle and its relation to the exiting roots is clearly evident.
Starting pedicular screw insertion, part of the cortical bone at the inferolateral edge of the superior facet is removed. This entry point lies exactly along the transverse plane passing through the middle of the corresponding transverse process.
At the same time the inferior and medial surfaces of the pedicle along with the exiting nerve root are clearly visualized, so all factors needed for correct pedicle screw insertion are available including the correct entry point, the mediolateral and craniocaudal orientation in addition to the visual protection provided from inside the canal to observe any medial or inferior pedicle violation.
The investigator used to insert a dissector inside the disc space as an additional guide to craniocaudal orientation of the screw which should be parallel to the disc space.
The process of pedicular screw insertion is completed as usual and the disc space is properly curetted using the suitable shavers then the prepared autologous bone graft is impacted in the disc space. The remaining screws are inserted and the rods are installed and secured as usual.
The time needed for each screw insertion was calculated. During the previous steps neither fluoroscopic guidance nor neuronavigation were used.
After completion of the previous steps, a single lateral and anteroposterior film was used to confirm the correct screw position.
The surgery is completed as usual and the patient is discharged for follow up after two weeks, during which a complementary CT scan lumbar spine is routinely performed and analyzed for the accuracy of the screw position.
Pedicle violation was assessed whether medial, inferior, lateral or superior.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| accuracy of pedicle screw insertion | Other | Procedure: pedicle screw fixationpostoperative CT lumbar spine axial and sagittal views. |
Who may qualify
- Ages
- 24 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- single level or double level degenerative spondylolisthesis
Key exclusion criteria (1 listed)
- other causes of spondylolisthesis
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 |
|---|---|---|
| pedicle screw fixationOne hundred forty four screws were placed in the lumbosacral pedicles of 32 patients using free hand technique depending on direct visualization of the pedicles, roots, and intervertebral disc ( IVD) after doing full laminectomy, then postoperative CT was done for evaluation of pedicle violation. | Procedure or surgery | accuracy of pedicle screw insertion |
Primary outcome
pedicle screw accuracy
Time frame: 2 weeks
Pedicle violation was assessed whether medial, inferior, lateral or superior using postoperative CT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing pedicle screw fixation in people with Lumbar Spondylolisthesis, run by Zagazig University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pedicle screw accuracy (time frame: 2 weeks). 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 31 Oct 2017.