Back to resultsAnalysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
Primary Purpose
Spinal Deformity, Spinal Infection, Trauma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pedicle screw instrumentation using Mazor X robotic system
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Deformity
Eligibility Criteria
Inclusion Criteria: ≥ 18 years old Degenerative conditions, spinal deformity, spinal infection, traumatic injuries, or neoplastic processes between T2-S1 necessitating placement of pedicle screw instrumentation. Surgery performed at The Ohio State University Wexner Medical Center (OSUWMC) via one of the study investigators Exclusion Criteria: Current or previous spinal tumor Severe co-morbidities (e.g., heart, respiratory, or renal disease) Concurrent involvement in another investigational drug or device study that could confound study data Subjects who are pregnant Prisoner Subjects who do not speak English Relative Exclusion Criteria Prior pedicle screw instrumentation at that level (i.e. prior L4-5 instrumentation, now undergoing an L4-S1 fusion, only new S1 screw accuracy would be evaluated in this patient)
Sites / Locations
- The Ohio State University Wexner Medical Center Neurological Surgery
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Single Arm. All participants undergoing posterior thoracolumbar arthrodesis procedures betweenT2-S1 in which preplanning is done using the Mazor X robotic system.
Outcomes
Primary Outcome Measures
Total deviation (mm) from the pre-planned screw entry point
Total deviation (mm) from the pre-planned screw entry point includes: deviation in angle of insertion in the axial plane (degrees), and deviation in angle of insertion in the sagittal plane (degrees) from an O-arm spin after screw placement.
Secondary Outcome Measures
Accuracy assessment for degree of pedicle breach
The secondary outcome will include traditional accuracy assessment for degree of pedicle breach utilizing the Gertzbein and Robbins classification system.
Full Information
NCT ID
NCT05884593
First Posted
March 15, 2023
Last Updated
October 23, 2023
Sponsor
Ohio State University
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT05884593
Brief Title
Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
Official Title
Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess screw deviation from pre-planned trajectory using the Mazor X robotic system in patients undergoing posterior thoracolumbar arthrodesis procedures between T2-S1.
Detailed Description
This trial will prospectively evaluate screw deviation from pre-planned trajectory using the standard of care Mazor X robotic system. Patients undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation at previously uninstrumented levels for degenerative conditions, spinal deformity, spinal infection, trauma, or neoplastic processes between T2-S1 will be asked to participate in this prospective cohort study.
This single centered study will enroll up to 50 patients to achieve a total number of 250 screws for assessment. Subjects will be followed till discharge following surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for posterior thoracolumbar arthrodesis surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Deformity, Spinal Infection, Trauma, Neoplastic Processes, Degenerative Spinal Conditions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Arm Description
Single Arm. All participants undergoing posterior thoracolumbar arthrodesis procedures betweenT2-S1 in which preplanning is done using the Mazor X robotic system.
Intervention Type
Device
Intervention Name(s)
Pedicle screw instrumentation using Mazor X robotic system
Intervention Description
Pedicle screw instrumentation using Mazor X robotic system
Primary Outcome Measure Information:
Title
Total deviation (mm) from the pre-planned screw entry point
Description
Total deviation (mm) from the pre-planned screw entry point includes: deviation in angle of insertion in the axial plane (degrees), and deviation in angle of insertion in the sagittal plane (degrees) from an O-arm spin after screw placement.
Time Frame
study completion average 2years
Secondary Outcome Measure Information:
Title
Accuracy assessment for degree of pedicle breach
Description
The secondary outcome will include traditional accuracy assessment for degree of pedicle breach utilizing the Gertzbein and Robbins classification system.
Time Frame
6 weeks post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years old
Degenerative conditions, spinal deformity, spinal infection, traumatic injuries, or neoplastic processes between T2-S1 necessitating placement of pedicle screw instrumentation.
Surgery performed at The Ohio State University Wexner Medical Center (OSUWMC) via one of the study investigators
Exclusion Criteria:
Current or previous spinal tumor
Severe co-morbidities (e.g., heart, respiratory, or renal disease)
Concurrent involvement in another investigational drug or device study that could confound study data
Subjects who are pregnant
Prisoner
Subjects who do not speak English Relative Exclusion Criteria
Prior pedicle screw instrumentation at that level (i.e. prior L4-5 instrumentation, now undergoing an L4-S1 fusion, only new S1 screw accuracy would be evaluated in this patient)
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center Neurological Surgery
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
1523519
Citation
Carl AL, Tromanhauser SG, Roger DJ. Pedicle screw instrumentation for thoracolumbar burst fractures and fracture-dislocations. Spine (Phila Pa 1976). 1992 Aug;17(8 Suppl):S317-24. doi: 10.1097/00007632-199208001-00018.
Results Reference
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19365256
Citation
Rose PS, Lenke LG, Bridwell KH, Mulconrey DS, Cronen GA, Buchowski JM, Schwend RM, Sides BA. Pedicle screw instrumentation for adult idiopathic scoliosis: an improvement over hook/hybrid fixation. Spine (Phila Pa 1976). 2009 Apr 15;34(8):852-7; discussion 858. doi: 10.1097/BRS.0b013e31818e5962.
Results Reference
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PubMed Identifier
27398897
Citation
Hyun SJ, Kim KJ, Jahng TA, Kim HJ. Minimally Invasive Robotic Versus Open Fluoroscopic-guided Spinal Instrumented Fusions: A Randomized Controlled Trial. Spine (Phila Pa 1976). 2017 Mar 15;42(6):353-358. doi: 10.1097/BRS.0000000000001778.
Results Reference
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PubMed Identifier
32470927
Citation
Jiang B, Pennington Z, Zhu A, Matsoukas S, Ahmed AK, Ehresman J, Mahapatra S, Cottrill E, Sheppell H, Manbachi A, Crawford N, Theodore N. Three-dimensional assessment of robot-assisted pedicle screw placement accuracy and instrumentation reliability based on a preplanned trajectory. J Neurosurg Spine. 2020 May 29:1-10. doi: 10.3171/2020.3.SPINE20208. Online ahead of print.
Results Reference
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PubMed Identifier
2326693
Citation
Gertzbein 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.
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PubMed Identifier
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Citation
Heary RF, Bono CM, Black M. Thoracic pedicle screws: postoperative computerized tomography scanning assessment. J Neurosurg. 2004 Apr;100(4 Suppl Spine):325-31. doi: 10.3171/spi.2004.100.4.0325.
Results Reference
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PubMed Identifier
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Citation
Wiesner L, Kothe R, Ruther W. Anatomic evaluation of two different techniques for the percutaneous insertion of pedicle screws in the lumbar spine. Spine (Phila Pa 1976). 1999 Aug 1;24(15):1599-603. doi: 10.1097/00007632-199908010-00015.
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PubMed Identifier
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Citation
Rampersaud YR, Pik JH, Salonen D, Farooq S. Clinical accuracy of fluoroscopic computer-assisted pedicle screw fixation: a CT analysis. Spine (Phila Pa 1976). 2005 Apr 1;30(7):E183-90. doi: 10.1097/01.brs.0000157490.65706.38.
Results Reference
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PubMed Identifier
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Citation
van Dijk JD, van den Ende RP, Stramigioli S, Kochling M, Hoss N. Clinical pedicle screw accuracy and deviation from planning in robot-guided spine surgery: robot-guided pedicle screw accuracy. Spine (Phila Pa 1976). 2015 Sep 1;40(17):E986-91. doi: 10.1097/BRS.0000000000000960.
Results Reference
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Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
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