Pedicle Screw Malposition in Spine Arthrodesis Surgeries With O-ARM-guided Navigation

NCT06020417 | Recruiting DMC FDA Device

• 1 other identifier: FUPiaui_No-HARM
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Throughout the history of spinal deformity there have been continuous advances in the surgical treatment. Although many techniques have been successfully developed despite the anatomy complex, screw placement still remains difficult with a significant risk of misplaced implants. The O-ARM guided Navigation is a scanner that allows imaging of screws intraoperatively and could be a tool to facilitate screw revision and reduce the occurrence of misplaced implants. Methods: This is a prospective and randomized clinical study that will be carried out at the University Hospital of the Federal University of Piaui, which provides exclusive assistance to patients of the Unified Health System (UHS), in northeastern Brazil.

Conditions

Spinal Fusion; Spinal Deformity; Spine Injury

Keywords

neuronavigation; spinal deformity; Spine injury

Outcome Measures

Primary Outcomes (1)

• misplaced implant

  medial and/or lateral deviations

  30 days

Secondary Outcomes (1)

• recurrent pain

  30 days

Study Arms (2)

O-Arm neuronavigator

ACTIVE COMPARATOR

The O-ARM imaging system can help surgeons to view the spine in real time and verify the placement of implants such as screws or rods. Primarily, therefore, in image acquisition, during surgery, the O-ARM is activated and generates real-time images of the patient's spine, so that these images are displayed on a screen, allowing the surgeon to visualize the anatomical structures and check that implant placement is proper. Therefore, when analyzing these images, the surgeon can, for example, analyze and verify the placement of the implants and ensure that the arthrodesis is performed correctly, in such a way that, if necessary, the surgeon can make adjustments and then acquire new images for verification.

Device: O-ARM (Medtronic, Inc, Louisville, CO)

Conventional

PLACEBO COMPARATOR

The conventional procedure for spinal arthrodesis will involve the intervertebral disc removal step between the vertebrae that will be fused. This is done precisely to create space for the bone graft that will be placed later. Then, there is bone surface preparation, where you prepare the bone surfaces of the vertebrae that will be fused, removing any soft tissue that might interfere with bone fusion. Then, there is bone graft placement, where the surgeon places a bone graft between the vertebrae that will be fused together. This graft can be obtained from another part of the patient's body (such as the pelvis) or from a deceased donor. Then, in the spinal column fixation step, rods, screws and/or plates are used to fix the vertebrae that will be fused.

Procedure: Conventional corrective surgery for arthrodesis

Interventions

O-ARM (Medtronic, Inc, Louisville, CO) DEVICE

scanner that allows imaging of screws intraoperatively

O-Arm neuronavigator

Conventional corrective surgery for arthrodesis PROCEDURE

Conventional procedure without neuronavigation guide

Conventional

Eligibility Criteria

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

You may qualify if:

• spine deformities (spinal cord trauma, osteoarthritis, intervertebral disc degeneration, degenerative or isthmic spondylolisthesis, intervertebral disc degeneration, spinal stenosis and degenerative scoliosis).

You may not qualify if:

• anatomical abnormalities that can not be used the neuronavigation.

Sponsors & Collaborators

• Federal University of Piaui: lead

Study Sites (1)

Carlos Eduardo Batista de Lima

Teresina, Piauí, 64048-350, Brazil

RECRUITING

Related Publications (2)

• Santos ER, Ledonio CG, Castro CA, Truong WH, Sembrano JN. The accuracy of intraoperative O-arm images for the assessment of pedicle screw postion. Spine (Phila Pa 1976). 2012 Jan 15;37(2):E119-25. doi: 10.1097/BRS.0b013e3182257cae.

  PMID: 21673628 BACKGROUND

• Perdomo-Pantoja A, Ishida W, Zygourakis C, Holmes C, Iyer RR, Cottrill E, Theodore N, Witham TF, Lo SL. Accuracy of Current Techniques for Placement of Pedicle Screws in the Spine: A Comprehensive Systematic Review and Meta-Analysis of 51,161 Screws. World Neurosurg. 2019 Jun;126:664-678.e3. doi: 10.1016/j.wneu.2019.02.217. Epub 2019 Mar 15.

  PMID: 30880208 BACKGROUND

MeSH Terms

Conditions

Spinal Injuries

Interventions

Arthrodesis

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Carlos Eduardo B Lima, MD, PhD

  Federal University of Piaui

  PRINCIPAL INVESTIGATOR

• Denilson G Italiano, Sr.

  Federal University of Piaui

  STUDY CHAIR

• Mauricio Giraldi, MD, MSc

  University Hospital of Federal University of Piaui

  STUDY CHAIR

Central Study Contacts

Carlos E Lima, MD, PhD

CONTACT

+5586981805000; carlos.lima@ufpi.edu.br

Denilson G Italiano, Sr.

CONTACT

+5586994804115; denilsonitaliano@ufpi.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Model Details: Comparison between the use or not of neuronavigation for corrective surgery of spinal deformity

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: August 31, 2023
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)