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The Spinal Navigation Trial - Surgical Navigation or Free Hand Technique in Spine Surgery

NCT05107310 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-02-21

No results posted yet for this study

Summary

The spinal navigation trial (SPINAV) is a randomized controlled trial (RCT) evaluating the use of computer-assisted navigation in surgery for spinal deformity

Conditions

  • Scoliosis
  • Kyphosis

Interventions

PROCEDURE

Pedicle screws insertion by free hand technique

Spinal deformity correction. Pedicle screws are inserted using free hand technique with the help of intraoperative fluoroscopy if needed.

PROCEDURE

Pedicle screws insertion using ARSN

Spinal deformity correction. Pedicle screws are inserted using augmented reality surgical navigation (ARSN) with the ClarifEye navigation system and the Philips Allura 2D/3D imaging system.

PROCEDURE

Pedicle screws insertion using IRSN

Spinal deformity correction. Pedicle screws are inserted using infra-red surgical navigation (IRSN) with the Brainlab Curve 1.2 navigation system combined with the Medtronic O-arm 2D/3D imaging system.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Uppsala University

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Paul Gerdhem, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2024-06-30
Completion
2029-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05107310 on ClinicalTrials.gov