Pedicle ScrewsNCT04196153
Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using O-arm Navigation VS Standard Cervical Distractor Screws
A study testing Pedicle screws instrumentation in people with Pedicle Screws and Surgery, Computer-Assisted/Adverse Effects, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial summary
Pedicle screw instrumentation is used nowadays mostly in spine fusion which is a surgical option for treating variety of conditions such as vertebral fractures, degenerative spine diseases, spine tumors and spine deformities. However, pedicle screws misplacement and breach may occur and be a great cause of morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pedicle Screws, Surgery, Computer-Assisted/Adverse Effects, Bone Screws
- What is being tested?
- Pedicle screws instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Oct 2019to Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who need a thoracolumbar spine surgery that require pedicle screw insertion.
Who cannot join
- Patients whose surgeries in cervical spine
- Patients whose surgeries are for correction of deformities such as scoliosis and kyphosis, patients with infections or tumors.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz Medical City
Jeddah, Eastern Province, 21423
Ahmad Deeb, +966-11-8011111 ext. 18950, deebah@NGHA.MED.SA
About this study
Official title: A Comparison of Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using Two Guidance Techniques: O-arm Navigation and Cervical Distractor Screws
Pedicle screw instrumentation is used nowadays mostly in spine fusion which is a surgical option for treating variety of conditions such as vertebral fractures, degenerative spine diseases, spine tumors and spine deformities. However, pedicle screws misplacement and breach may occur and be a great cause of morbidity. The breach rate can be as high as 20-39.8% but most of the time only small number is associated with complications. Surgeons use assistive technique to avoid screw breached and improve screw placement accuracy. Investigators aim in this study to compare accuracy of pedicle screws placement using two guidance techniques are O-arm navigation the latest assistive imaging technique that uses three-dimensional (3-D) real time images to allow the surgeons follow the screw's trajectory, and standard cervical distractor screws to mark the entry point and trajectory.
- Conditions
- Pedicle Screws, Surgery, Computer-Assisted/Adverse Effects, Bone Screws, Imaging, Three-Dimensional/Methods
- Being tested
- Pedicle screws instrumentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedicle screws instrumentationProcedure or surgery
The screws are inserted in two or more consecutive levels to prevent motion at the segments that are being fused. It will be done using one of the two guidance technique depending on which arm the patient will be randomized to.
| Study group | Role | What they receive |
|---|---|---|
| Neuronavigation / O-arm group | Active comparator | Under neural navigation with the use of intraoperative three dimensional imaging quality O-arm , pedicle screws inserted at the thoraolumbar/lumbar spine after insertion of the reference frame at the spinous process above or below the level of instrumentation followed by O-Arm imaging and uploading the images to the stelth navigation system and pedicle tract identification using instrumented tools guided by the Navigation polyaxial screws is inserted. Receives: Procedure: Pedicle screws instrumentation |
| Cervical distractor screws group | Active comparator | pedicle screws inserted using marker screws after posterior exposure of thoracolumbar /lumbar spine by either open midline posterior exposure or minimal invasive posterior wiltse style exposure with expandable tubular retractor, anatomical landmark for insertion of pedical screws identified and followed by inserting of a cervical distraction screw size 3 / 12 mm as a stable marker using high speed drill. C-arm floro is used to take antroposterior and lateral view to confirm the position of the marker screws at this stage.free hand technique supported by the images provided to cannulate the pedicle with the use of information on the images taken for all the marker screws simultaneously. Receives: Procedure: Pedicle screws instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate screws breach
Investigators will determine the rate of screws breach in the two comparison groups
Measured: 6 months
Screw insertion time
screw insertion time in each technique which will be assessed by calculating the total time from puncture at the entry point by awl to complete all screw insertions into pedicles divided by the number of pedicle screws
Measured: 5 hours
screws revision times
investigators will determine which group needs more screws revision
Measured: 6 months
degree of screws breach
Investigators will determine degree of screws breach in the two comparison groups
Measured: 6 months
Secondary outcomes (2)
Direction of the breach
investigators will ascertain direction of the breach, if it is lateral ,medial , inferior , or superior.
Measured: 6 months
complications
the two groups will be compared in rate of neurological or vascular complications.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start10 Oct 2019
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pedicle ScrewsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed A Khashab, MD, Principal investigator, Assistant Professor of Orthopedic, College of Medicine, KSAU-HS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196153
- Sponsor's protocol ID
- kashabmo
- Status last verified
- Sep 2020
- First submitted
- 7 Dec 2019
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
BOUCHER HH. A method of spinal fusion. J Bone Joint Surg Br. 1959 May;41-B(2):248-59. doi: 10.1302/0301-620X.41B2.248. No abstract available.
PubMed 13641310Gaines RW Jr. The use of pedicle-screw internal fixation for the operative treatment of spinal disorders. J Bone Joint Surg Am. 2000 Oct;82(10):1458-76. doi: 10.2106/00004623-200010000-00013.
PubMed 11057475Liljenqvist UR, Halm HF, Link TM. Pedicle screw instrumentation of the thoracic spine in idiopathic scoliosis. Spine (Phila Pa 1976). 1997 Oct 1;22(19):2239-45. doi: 10.1097/00007632-199710010-00008.
PubMed 9346144Krag MH, Beynnon BD, Pope MH, DeCoster TA. Depth of insertion of transpedicular vertebral screws into human vertebrae: effect upon screw-vertebra interface strength. J Spinal Disord. 1988;1(4):287-94. doi: 10.1097/00002517-198800140-00002.
PubMed 2980257Roy-Camille R, Saillant G, Mazel C. Internal fixation of the lumbar spine with pedicle screw plating. Clin Orthop Relat Res. 1986 Feb;(203):7-17.
PubMed 3955999Broom MJ, Banta JV, Renshaw TS. Spinal fusion augmented by luque-rod segmental instrumentation for neuromuscular scoliosis. J Bone Joint Surg Am. 1989 Jan;71(1):32-44.
PubMed 2913001Puvanesarajah V, Liauw JA, Lo SF, Lina IA, Witham TF. Techniques and accuracy of thoracolumbar pedicle screw placement. World J Orthop. 2014 Apr 18;5(2):112-23. doi: 10.5312/wjo.v5.i2.112. eCollection 2014 Apr 18.
PubMed 24829874Vaccaro AR, Rizzolo SJ, Balderston RA, Allardyce TJ, Garfin SR, Dolinskas C, An HS. Placement of pedicle screws in the thoracic spine. Part II: An anatomical and radiographic assessment. J Bone Joint Surg Am. 1995 Aug;77(8):1200-6. doi: 10.2106/00004623-199508000-00009.
PubMed 7642665Verma R, Krishan S, Haendlmayer K, Mohsen A. Functional outcome of computer-assisted spinal pedicle screw placement: a systematic review and meta-analysis of 23 studies including 5,992 pedicle screws. Eur Spine J. 2010 Mar;19(3):370-5. doi: 10.1007/s00586-009-1258-4. Epub 2010 Jan 6.
PubMed 20052504Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990 Jan;15(1):11-4. doi: 10.1097/00007632-199001000-00004.
PubMed 2326693Kim TT, Drazin D, Shweikeh F, Pashman R, Johnson JP. Clinical and radiographic outcomes of minimally invasive percutaneous pedicle screw placement with intraoperative CT (O-arm) image guidance navigation. Neurosurg Focus. 2014 Mar;36(3):E1. doi: 10.3171/2014.1.FOCUS13531.
PubMed 24580001Luo TD, Polly DW Jr, Ledonio CG, Wetjen NM, Larson AN. Accuracy of Pedicle Screw Placement in Children 10 Years or Younger Using Navigation and Intraoperative CT. Clin Spine Surg. 2016 Apr;29(3):E135-8. doi: 10.1097/BSD.0000000000000230.
PubMed 27007788Scarone P, Vincenzo G, Distefano D, Del Grande F, Cianfoni A, Presilla S, Reinert M. Use of the Airo mobile intraoperative CT system versus the O-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients. J Neurosurg Spine. 2018 Oct;29(4):397-406. doi: 10.3171/2018.1.SPINE17927. Epub 2018 Jul 6.
PubMed 29979141Tajsic T, Patel K, Farmer R, Mannion RJ, Trivedi RA. Spinal navigation for minimally invasive thoracic and lumbosacral spine fixation: implications for radiation exposure, operative time, and accuracy of pedicle screw placement. Eur Spine J. 2018 Aug;27(8):1918-1924. doi: 10.1007/s00586-018-5587-z. Epub 2018 Apr 17.
PubMed 29667139
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using Two Guidance Techniques: O-arm Navigation and Cervical Distractor Screws
- ClinicalTrials.gov ID
- NCT04196153
- Acronym / sponsor ID
- kashabmo
- Conditions
- Pedicle Screws, Surgery, Computer-Assisted/Adverse Effects, Bone Screws, Imaging, Three-Dimensional/Methods
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 12 Dec 2019 (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.
Pedicle screw instrumentation is used nowadays mostly in spine fusion which is a surgical option for treating variety of conditions such as vertebral fractures, degenerative spine diseases, spine tumors and spine deformities. However, pedicle screws misplacement and breach may occur and be a great cause of morbidity. The breach rate can be as high as 20-39.8% but most of the time only small number is associated with complications. Surgeons use assistive technique to avoid screw breached and improve screw placement accuracy. Investigators aim in this study to compare accuracy of pedicle screws placement using two guidance techniques are O-arm navigation the latest assistive imaging technique that uses three-dimensional (3-D) real time images to allow the surgeons follow the screw's trajectory, and standard cervical distractor screws to mark the entry point and trajectory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuronavigation / O-arm group | Active comparator | Procedure: Pedicle screws instrumentationUnder neural navigation with the use of intraoperative three dimensional imaging quality O-arm , pedicle screws inserted at the thoraolumbar/lumbar spine after insertion of the reference frame at the spinous process above or below the level of instrumentation followed by O-Arm imaging and uploading the images to the stelth navigation system and pedicle tract identification using instrumented tools guided by the Navigation polyaxial screws is inserted. |
| Cervical distractor screws group | Active comparator | Procedure: Pedicle screws instrumentationpedicle screws inserted using marker screws after posterior exposure of thoracolumbar /lumbar spine by either open midline posterior exposure or minimal invasive posterior wiltse style exposure with expandable tubular retractor, anatomical landmark for insertion of pedical screws identified and followed by inserting of a cervical distraction screw size 3 / 12 mm as a stable marker using high speed drill. C-arm floro is used to take antroposterior and lateral view to confirm the position of the marker screws at this stage.free hand technique supported by the images provided to cannulate the pedicle with the use of information on the images taken for all the marker screws simultaneously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who need a thoracolumbar spine surgery that require pedicle screw insertion.
Key exclusion criteria (2 listed)
- Patients whose surgeries in cervical spine
- Patients whose surgeries are for correction of deformities such as scoliosis and kyphosis, patients with infections or tumors.
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 screws instrumentationThe screws are inserted in two or more consecutive levels to prevent motion at the segments that are being fused. It will be done using one of the two guidance technique depending on which arm the patient will be randomized to. | Procedure or surgery | Cervical distractor screws group, Neuronavigation / O-arm group |
Primary outcome
Rate screws breach
Time frame: 6 months
Investigators will determine the rate of screws breach in the two comparison groups
Screw insertion time
Time frame: 5 hours
screw insertion time in each technique which will be assessed by calculating the total time from puncture at the entry point by awl to complete all screw insertions into pedicles divided by the number of pedicle screws
screws revision times
Time frame: 6 months
investigators will determine which group needs more screws revision
degree of screws breach
Time frame: 6 months
Investigators will determine degree of screws breach in the two comparison groups
2 secondary outcomes
Direction of the breach
Time frame: 6 months
complications
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Background: PubMed 13641310BOUCHER HH. A method of spinal fusion. J Bone Joint Surg Br. 1959 May;41-B(2):248-59. doi: 10.1302/0301-620X.41B2.248. No abstract available.
- Background: PubMed 11057475Gaines RW Jr. The use of pedicle-screw internal fixation for the operative treatment of spinal disorders. J Bone Joint Surg Am. 2000 Oct;82(10):1458-76. doi: 10.2106/00004623-200010000-00013.
- Background: PubMed 9346144Liljenqvist UR, Halm HF, Link TM. Pedicle screw instrumentation of the thoracic spine in idiopathic scoliosis. Spine (Phila Pa 1976). 1997 Oct 1;22(19):2239-45. doi: 10.1097/00007632-199710010-00008.
- Background: PubMed 2980257Krag MH, Beynnon BD, Pope MH, DeCoster TA. Depth of insertion of transpedicular vertebral screws into human vertebrae: effect upon screw-vertebra interface strength. J Spinal Disord. 1988;1(4):287-94. doi: 10.1097/00002517-198800140-00002.
- Background: PubMed 3955999Roy-Camille R, Saillant G, Mazel C. Internal fixation of the lumbar spine with pedicle screw plating. Clin Orthop Relat Res. 1986 Feb;(203):7-17.
- Background: PubMed 2913001Broom MJ, Banta JV, Renshaw TS. Spinal fusion augmented by luque-rod segmental instrumentation for neuromuscular scoliosis. J Bone Joint Surg Am. 1989 Jan;71(1):32-44.
- Background: PubMed 24829874Puvanesarajah V, Liauw JA, Lo SF, Lina IA, Witham TF. Techniques and accuracy of thoracolumbar pedicle screw placement. World J Orthop. 2014 Apr 18;5(2):112-23. doi: 10.5312/wjo.v5.i2.112. eCollection 2014 Apr 18.
- Background: PubMed 7642665Vaccaro AR, Rizzolo SJ, Balderston RA, Allardyce TJ, Garfin SR, Dolinskas C, An HS. Placement of pedicle screws in the thoracic spine. Part II: An anatomical and radiographic assessment. J Bone Joint Surg Am. 1995 Aug;77(8):1200-6. doi: 10.2106/00004623-199508000-00009.
- Background: PubMed 20052504Verma R, Krishan S, Haendlmayer K, Mohsen A. Functional outcome of computer-assisted spinal pedicle screw placement: a systematic review and meta-analysis of 23 studies including 5,992 pedicle screws. Eur Spine J. 2010 Mar;19(3):370-5. doi: 10.1007/s00586-009-1258-4. Epub 2010 Jan 6.
- Background: PubMed 2326693Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990 Jan;15(1):11-4. doi: 10.1097/00007632-199001000-00004.
- Background: PubMed 24580001Kim TT, Drazin D, Shweikeh F, Pashman R, Johnson JP. Clinical and radiographic outcomes of minimally invasive percutaneous pedicle screw placement with intraoperative CT (O-arm) image guidance navigation. Neurosurg Focus. 2014 Mar;36(3):E1. doi: 10.3171/2014.1.FOCUS13531.
- Background: PubMed 27007788Luo TD, Polly DW Jr, Ledonio CG, Wetjen NM, Larson AN. Accuracy of Pedicle Screw Placement in Children 10 Years or Younger Using Navigation and Intraoperative CT. Clin Spine Surg. 2016 Apr;29(3):E135-8. doi: 10.1097/BSD.0000000000000230.
- Individual participant dataSharing planned: Undecided
Related trials for Pedicle Screws
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Not yet recruitingObservational study
Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery
Thoracolumbar Spinal Fusion
Not yet recruitingObservational study
Analysis of Sub Axial Cervical Pedicle Spine Based on CT
Cervical Pedicle Screw
Active, not recruitingObservational study
Evaluation of Safety of Complex Pedicle Screw Trajectories Using Patient-Specific Guides (MySpine, Medacta)
Scoliosis Idiopathic, Scoliosis Idiopathic Adolescent
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.
Mohammed A Khashab, MD principal investigator
Assistant Professor of Orthopedic, College of Medicine, KSAU-HS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedicle screws instrumentation in people with Pedicle Screws and Surgery, Computer-Assisted/Adverse Effects, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Sep 2020. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muath M Alswat, MD (966548496502, alswat016@ksau-hs.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate screws breach (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04196153, which also lists 14 linked publications.
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 7 Sep 2020.