Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System

NCT05884593 | Active Not Recruiting FDA Device

• 1 other identifier: 2020H0434
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Deformity; Spinal Infection; Trauma; Neoplastic Processes; Degenerative Spinal Conditions

Outcome Measures

Primary Outcomes (1)

• 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.

  study completion average 2years

Secondary Outcomes (1)

• Accuracy assessment for degree of pedicle breach

  6 weeks post surgery

Study Arms (1)

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.

Device: Pedicle screw instrumentation using Mazor X robotic system

Interventions

Pedicle screw instrumentation using Mazor X robotic system DEVICE

Pedicle screw instrumentation using Mazor X robotic system

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Ohio State University: lead
• Medtronic: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center Neurological Surgery

Columbus, Ohio, 43219, United States

Location

Related Publications (9)

• 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.

  PMID: 1523519 BACKGROUND

• 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.

  PMID: 19365256 BACKGROUND

• 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.

  PMID: 27398897 BACKGROUND

• 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;33(4):519-528. doi: 10.3171/2020.3.SPINE20208. Print 2020 Oct 1.

  PMID: 32470927 BACKGROUND

• 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.

  PMID: 2326693 BACKGROUND

• 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.

  PMID: 15070139 BACKGROUND

• 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.

  PMID: 10457581 BACKGROUND

• 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.

  PMID: 15803068 BACKGROUND

• 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.

  PMID: 25943084 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Neoplastic Processes

Condition Hierarchy (Ancestors)

Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor Residency Program Director Deformity and Robotic Spinal Fellowship Director

Model Details: All subjects will undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: June 1, 2023
• Study Start: March 5, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 30, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)