Spinal DeformityNCT05884593
Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
A study testing Pedicle screw instrumentation using Mazor X robotic system in people with Spinal Deformity and Spinal Infection, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Deformity, Spinal Infection, Trauma
- What is being tested?
- Pedicle screw instrumentation using Mazor X robotic system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 23 Feb 2026
- 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
- ≥ 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center Neurological Surgery
Columbus, Ohio, 43219
About this study
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.
Read the 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.
- Conditions
- Spinal Deformity, Spinal Infection, Trauma, Neoplastic Processes, Degenerative Spinal Conditions
- Being tested
- Pedicle screw instrumentation using Mazor X robotic system
- Medical subject headings
- Wounds and Injuries, Neoplastic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedicle screw instrumentation using Mazor X robotic systemDevice
Pedicle screw instrumentation using Mazor X robotic system
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Single Arm. All participants undergoing posterior thoracolumbar arthrodesis procedures betweenT2-S1 in which preplanning is done using the Mazor X robotic system. Receives: Device: Pedicle screw instrumentation using Mazor X robotic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: study completion average 2years
Secondary outcomes (1)
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.
Measured: 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start5 Mar 2021
- Primary completion31 Dec 2023
- Study completion23 Feb 2026
Why it stopped: The study was prematurely terminated despite completion of study activities, as final data analysis could not be conducted due to operational disruptions caused by the war in Gaza. These circumstances were beyond the sponsor's and site's control.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Model description
- All subjects will undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Andrew Grossbach, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884593
- Sponsor's protocol ID
- 2020H0434
- Status last verified
- Aug 2025
- First submitted
- 15 Mar 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 1523519Rose 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.
PubMed 19365256Hyun 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.
PubMed 27398897Jiang 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;33(4):519-528. doi: 10.3171/2020.3.SPINE20208. Print 2020 Oct 1.
PubMed 32470927Gertzbein 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 2326693Heary 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.
PubMed 15070139Wiesner 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.
PubMed 10457581Rampersaud 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.
PubMed 15803068van 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.
PubMed 25943084
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
- ClinicalTrials.gov ID
- NCT05884593
- Acronym / sponsor ID
- 2020H0434
- Conditions
- Spinal Deformity, Spinal Infection, Trauma, Neoplastic Processes, Degenerative Spinal Conditions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated despite completion of study activities, as final data analysis could not be conducted due to operational disruptions caused by the war in Gaza. These circumstances were beyond the sponsor's and site's control.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 1 Jun 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Device: Pedicle screw instrumentation using Mazor X robotic systemSingle Arm. All participants undergoing posterior thoracolumbar arthrodesis procedures betweenT2-S1 in which preplanning is done using the Mazor X robotic system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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
Key exclusion criteria (7 listed)
- 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
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 instrumentation using Mazor X robotic systemPedicle screw instrumentation using Mazor X robotic system | Device | Arm 1 |
Primary outcome
Total deviation (mm) from the pre-planned screw entry point
Time frame: study completion average 2years
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.
1 secondary outcome
Accuracy assessment for degree of pedicle breach
Time frame: 6 weeks post surgery
Results and safety
The study was stopped early (reason given: The study was prematurely terminated despite completion of study activities, as final data analysis could not be conducted due to operational disruptions caused by the war in Gaza. These circumstances were beyond the sponsor's and site's control.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 1523519Carl 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.
- Background: PubMed 19365256Rose 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.
- Background: PubMed 27398897Hyun 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.
- Background: PubMed 32470927Jiang 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;33(4):519-528. doi: 10.3171/2020.3.SPINE20208. Print 2020 Oct 1.
- 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 15070139Heary 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.
- Background: PubMed 10457581Wiesner 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.
- Background: PubMed 15803068Rampersaud 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.
- Background: PubMed 25943084van 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.
- 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.
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 screw instrumentation using Mazor X robotic system in people with Spinal Deformity and Spinal Infection, run by Ohio State University at 1 site in United States.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 16 Oct 2026. 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 United States. 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?
The study was stopped early (reason given: The study was prematurely terminated despite completion of study activities, as final data analysis could not be conducted due to operational disruptions caused by the war in Gaza. These circumstances were beyond the sponsor's and site's control.). Results are not available in the source record.
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?
Total deviation (mm) from the pre-planned screw entry point (time frame: study completion average 2years). 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 NCT05884593, which also lists 9 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 16 Oct 2026.