Pedicle Screw Malposition in Spine Arthrodesis Surgeries With O-ARM-guided Navigation (NoHARM)
Occurrence of Pedicle Screw Malposition in Spine Arthrodesis Surgeries Performed With O-ARM-guided Navigation at a University Hospital: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design: This is a prospective and randomized clinical study. Local: The study will be carried out at the University Hospital of the Federal University of Piauí (UH-FUPI), which provides exclusive assistance to patients of the Unified Health System (UHS), in the municipality of Teresina (PI), in northeastern Brazil, in the surgical center sector, involving patients undergoing neurosurgical procedures. Data collection will begin after approval by the UH-FUPI research ethics committee. Population and sample: The study population will consist of patients hospitalized for spinal deformities in the wards of the University Hospital of the Federal University of Piauí (UH-FUPI).
Patients aged 18 years or older with surgical indication for spine arthrodesis will be included in the study and will be randomized for corrective neurological or orthopedic spine surgeries performed with O-Arm technology (Intervention Group) and without O-arm (Group control). The surgeries performed electively in the three segments of the spine will be included in this study. Patients who do not sign the informed consent form and those without adequate records in medical records that do not allow the analysis of the data provided for this research will be excluded. Sample size: The sample size of the present study was calculated with the aim of comparing the incidence of misplacement of screws between two approaches, the first using a navigator and the other without. Setting the power of the test at 80% and the confidence level at 95%, the incidence of misplacement of screws known in the literature with the use of a navigator is = 9.8% and without use = 15%. Thus, at least 496 screws would be needed in each arm of the study. Using data from the study by Jin, Liu, Qiu et al. (2017), we noticed that 1145 screws were inserted in 144 patients, generating an average of approximately 8 screws per patient. Thus, at least 62 patients would be needed in each arm. The calculations necessary to determine the sample size were performed by the formula where, is the order percentile of the standard normal distribution, is the order percentile of the standard normal distribution, is the proportion of screw misplacement without using the navigator, is proportion of screw misplacement using the navigator and is the midpoint of the proportions. Data collect: Data will be collected through medical records, which will be completed in the data collection form, after the procedure. The variables analyzed will be: type of surgery performed, technique used, which vertebrae underwent surgical intervention with the implantation of screws, number of screws in each vertebra, presence or not of invasion of the pedicle cortex after analysis with CT, in addition to the description of the affected vertebra , which screws invaded, measurement of invasion, in millimeters, and whether the position was medial or lateral. Statistical analysis: The collected data will be organized in tables and graphs. The program used to carry out the statistical tests will be SPSS Statistics. The method used to jointly analyze the relationship between the studied variables and the presence or absence of expected outcomes will be the Pearson chi-square test method. The admitted confidence interval is 95% and the p-value less than 0.05.
Ethical and legal aspects: All patients included will sign the informed consent form. Data collection will begin after approval of the study by the research ethics committee. All research ethics regulations will be followed according to the resolution of the National Health Council n° 466/12. Risks and benefits: The research risks involve the exposure of personal data and embarrassment to the participants. To work around such problems, patients will be identified by numbering, where only the researchers will have direct access to the patients' records, without photos or any record that could cause the dissemination of personal information. In addition, questions to participants will be asked with caution and empathy, in order to avoid any embarrassment to the patient. If it is demonstrated that the studied neurovagegation system significantly reduces the need for surgical repositioning of the pedicle screws, in addition to the benefit for the sample patient in the intervention group, who will not have to face yet another surgical approach, the FUPI may also be benefited, since the hospital will have, within its list, the option of a neuronavigation technology that brings real results to the hospital's patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carlos E Lima, MD, PhD
- Phone Number: +5586981805000
- Email: carlos.lima@ufpi.edu.br
Study Contact Backup
- Name: Denilson G Italiano, Sr.
- Phone Number: +5586994804115
- Email: denilsonitaliano@ufpi.edu.br
Study Locations
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Piauí
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Teresina, Piauí, Brazil, 64048-350
- Recruiting
- Carlos Eduardo Batista de Lima
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Contact:
- Carlos Eduardo B de Lima, MD, PhD
- Phone Number: 86981805000
- Email: carlos.lima@ufpi.edu.br
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Contact:
- Amanda Sousa
- Phone Number: 86994615203
- Email: admin@cardiolima.com.br
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- spine deformities (spinal cord trauma, osteoarthritis, intervertebral disc degeneration, degenerative or isthmic spondylolisthesis, intervertebral disc degeneration, spinal stenosis and degenerative scoliosis).
Exclusion Criteria:
- anatomical abnormalities that can not be used the neuronavigation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: O-Arm neuronavigator
The O-ARM imaging system can help surgeons to view the spine in real time and verify the placement of implants such as screws or rods.
Primarily, therefore, in image acquisition, during surgery, the O-ARM is activated and generates real-time images of the patient's spine, so that these images are displayed on a screen, allowing the surgeon to visualize the anatomical structures and check that implant placement is proper.
Therefore, when analyzing these images, the surgeon can, for example, analyze and verify the placement of the implants and ensure that the arthrodesis is performed correctly, in such a way that, if necessary, the surgeon can make adjustments and then acquire new images for verification.
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scanner that allows imaging of screws intraoperatively
|
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Placebo Comparator: Conventional
The conventional procedure for spinal arthrodesis will involve the intervertebral disc removal step between the vertebrae that will be fused.
This is done precisely to create space for the bone graft that will be placed later.
Then, there is bone surface preparation, where you prepare the bone surfaces of the vertebrae that will be fused, removing any soft tissue that might interfere with bone fusion.
Then, there is bone graft placement, where the surgeon places a bone graft between the vertebrae that will be fused together.
This graft can be obtained from another part of the patient's body (such as the pelvis) or from a deceased donor.
Then, in the spinal column fixation step, rods, screws and/or plates are used to fix the vertebrae that will be fused.
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Conventional procedure without neuronavigation guide
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
misplaced implant
Time Frame: 30 days
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medial and/or lateral deviations
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30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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recurrent pain
Time Frame: 30 days
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ocurrence of posoperative pain and persistence of symptoms after surgery
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos Eduardo B Lima, MD, PhD, Federal University of Piaui
- Study Chair: Denilson G Italiano, Sr., Federal University of Piaui
- Study Chair: Mauricio Giraldi, MD, MSc, University Hospital of Federal University of Piaui
Publications and helpful links
General Publications
- Santos ER, Ledonio CG, Castro CA, Truong WH, Sembrano JN. The accuracy of intraoperative O-arm images for the assessment of pedicle screw postion. Spine (Phila Pa 1976). 2012 Jan 15;37(2):E119-25. doi: 10.1097/BRS.0b013e3182257cae.
- Perdomo-Pantoja A, Ishida W, Zygourakis C, Holmes C, Iyer RR, Cottrill E, Theodore N, Witham TF, Lo SL. Accuracy of Current Techniques for Placement of Pedicle Screws in the Spine: A Comprehensive Systematic Review and Meta-Analysis of 51,161 Screws. World Neurosurg. 2019 Jun;126:664-678.e3. doi: 10.1016/j.wneu.2019.02.217. Epub 2019 Mar 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUPiaui_No-HARM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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