Clinical trial · Interventional
Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
NCT05884593CI-TRIAL-00093472active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Degenerative Spinal Conditions | — | UNRESOLVED | — |
| Neoplastic Processes | — | UNRESOLVED | — |
| Spinal Deformity | — | UNRESOLVED | — |
| Spinal Infection | — | UNRESOLVED | — |
| Trauma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pedicle screw instrumentation using Mazor X robotic system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Arm 1
- description
- Single Arm. All participants undergoing posterior thoracolumbar arthrodesis procedures betweenT2-S1 in which preplanning is done using the Mazor X robotic system.
- interventionNames
- Device: Pedicle screw instrumentation using Mazor X robotic system
Primary outcomes (1)
- measure
- Total deviation (mm) from the pre-planned screw entry point
- timeFrame
- study completion average 2years
- 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.
Secondary outcomes (1)
- measure
- Accuracy assessment for degree of pedicle breach
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (9)
- BACKGROUNDCarl 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. PMID 1523519
- BACKGROUNDRose 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. PMID 19365256
- BACKGROUNDHyun 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. PMID 27398897
- BACKGROUNDJiang 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. PMID 32470927
- BACKGROUNDGertzbein 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. PMID 2326693
- BACKGROUNDHeary 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. PMID 15070139
- BACKGROUNDWiesner 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.