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
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