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NCT Number: NCT05107310

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Scoliosis Bone Diseases Kyphosis Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 14186, Sweden

About this study

Spinal deformity is a common reason for spinal surgery at youth. In addition, the incidence of surgery for spinal deformity in older adults is increasing. Spinal deformity surgery is by far the most complex spine surgery. One complexity lies in the correct placement of implants in the severely deformed spine. Today, the most common surgical procedures for spinal deformity involve placement of screws in the vertebral pedicle in the instrumented part of the spine. This gives good bone purchase, which is important for deformity correction.

The pedicle is narrow and misplaced pedicle screws can result in vascular, pulmonary or neural injuries, or inadequate bone purchase. Compared to the conventional free-hand surgical technique, which relies on the knowledge of anatomy, computer-assisted navigation using intraoperative 3D imaging has been shown to improve screw placement accuracy and reduce complications due to screw misplacements. As a consequence, navigation may also reduce the frequency of postoperative revision surgery compared to free hand. However, navigation still takes time, and is associated with higher intraoperative radiation than the free hand technique.

As of yet, the majority of data in this area are based on retrospectively collected series, and some prospectively collected series, while randomized controlled trials on spinal deformity are lacking.

In this randomized controlled trial the accuracy of pedicle screw placement using augmented reality surgical navigation (ARSN), infra-red surgical navigation (IRSN) and conventional free-hand technique will be investigated.

Patients of age 12 years and older with spinal deformities are randomized into one of the three surgical techniques mentioned above.

The primary outcome variable is pedicle screw placement accuracy at 1st attempt assessed using the Gertzbein scale.

Data from the navigated groups (ASRN and IRSN) will be analyzed together, and compared with the free hand groups analyzed together. The ASRN and ISRN groups will also be compared with their respective free hand groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent by patient or legal guardian
  • Age 12 years and older
  • Spinal deformity surgery

Exclusion criteria

  • Unable to give informed consent
  • Surgery without pedicle screws
  • Previous surgery with pedicle screws in the planned surgical area

Treatment and study plan

Pedicle screws insertion by free hand technique

Procedure

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

Pedicle screws insertion using ARSN

Procedure

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.

Pedicle screws insertion using IRSN

Procedure

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.

Primary outcomes

  1. Accurately placed pedicle screws

    Time frame: Intraoperative

    The primary endpoint is the percentage of accurately placed pedicle screws assessed using the Gertzbein scale and based on intraoperative verification scan cone beam computed tomography (CBCT).

Secondary outcomes

  1. Pedicle screw intraoperative revision rates-clinical assessment

    Time frame: Intraoperative

    Number of screws intraoperatively revised based on clinical assessment

  2. Pedicle screw intraoperative revision rates- neurophysiology

    Time frame: Intraoperative

    Number of screws intraoperatively revised based on neurophysiology

  3. Pedicle screw intraoperative revision rates- intraoperative verification

    Time frame: Intraoperative

    Number of screws intraoperatively revised based on intraoperative verification CBCT scan

  4. Accuracy for ARSN - path deviation in mm

    Time frame: Intraoperative

    Deviation from planned navigated path in mm at bone entry and screw tip measured on the postoperative computed tomography (CT)

  5. Accuracy for IRSN- path deviation in mm

    Time frame: Intraoperative

    Deviation from navigated path in mm at bone entry and screw tip measured on the postoperative computed tomography (CT)

  6. Accuracy for ARSN - angular deviation

    Time frame: Intraoperative

    Angular deviation (degrees) of the placed screw compared to the planned navigated path measured on the postoperative computed tomography (CT)

  7. Accuracy for IRSN - angular deviation

    Time frame: Intraoperative

    Angular deviation of the placed screw compared to the navigated path measured on the postoperative computed tomography (CT)

  8. Accuracy at 1st attempt

    Time frame: Intraoperative

    Accuracy at 1st attempt = (Screws placed at first attempt according to intraoperative protocols and graded 0 or 1) / (total number of placed screws).

    Assessed on intraoperative CBCT

  9. Final accuracy of placed pedicle screws

    Time frame: Intraoperative

    Final accuracy of placed pedicle screws is calculated as: number of accurately placed screws (Gertzbein grade 0+1) according to postoperative CT / total number of placed screws.

  10. Pedicle screw placement density

    Time frame: Intraoperative

    The study aims for 100% pedicle screw density. Hooks may be placed as rescue or if screw placement fails.

  11. Pedicle screw placement in relation to morphometric measurements

    Time frame: Preoperative and intraoperative

    Pedicle diameters are measured on preoperative and intraoperative CT. Pedicle screw placement measured on intraoperative and postoperative CT.

  12. Deformity correction change

    Time frame: 3-6 months post-op

    Cobb angle change from preoperative to first erect postoperative radiograph

  13. Patient radiation dose exposure

    Time frame: Intraoperative

    Patient radiation exposure (ED in mSv) for the whole procedure, Patient radiation exposure (ED in mSv) for fluoroscopy Patient radiation exposure (ED in mSv) for each CBCT

  14. Staff radiation dose exposure

    Time frame: Intraoperative

    Average staff radiation exposure (in mSv) for the whole procedure

  15. Intraoperative characteristics- procedure time

    Time frame: Intraoperative

    Total procedure time as well as normalized to number of spinal levels from the upper to the lower instrumented vertebra.

  16. Intraoperative characteristics- planning time

    Time frame: Intraoperative

    Intraoperative planning time (from start of planning in navigation software until last screw planned) (only when treated with ARSN or IRSN)

  17. Intraoperative characteristics- instrumentation time

    Time frame: Intraoperative

    Instrumentation time (total time for navigated/FH screw placement from first to last screw placement)

  18. Intraoperative characteristics- instrumentation time/level

    Time frame: Intraoperative

    Instrumentation time normalized to number of levels

  19. Intraoperative characteristics- time for verification imaging

    Time frame: Intraoperative

    Time for intraoperative verification imaging (CBCT and/or Fluoroscopy)

  20. Intraoperative characteristics- screw placement time

    Time frame: Intraoperative

    Screw placement time (per screw, from start with awl to screw placed)

  21. Intraoperative characteristics- blood loss

    Time frame: Intraoperative

    Intraoperative blood loss

  22. Inpatient stay

    Time frame: Measured from day of surgery until day of discharge. Usual length of stay is less than one week, and maximum two weeks.

    Length of hospital stay in days

  23. Patient reported outcome measures- Scoliosis Research Society 22 revised (SRS-22r)

    Time frame: up to 5 years

    The scoliosis specific questionnaire SRS-22r ranging from 1 (worst) to 5 (best)

  24. Patient reported outcome measures- the 24 item Early Onset Scoliosis Questionnaire (EOSQ-24)

    Time frame: up to 5 years

    The scoliosis specific questionnaire EOSQ-24 ranging from 0 (worst) to 100 (best)

  25. Patient reported outcome measures- Oswestry Disability Index (ODI)

    Time frame: up to 5 years

    The back disabiliy questionnaire (ODI) ranging from 0 (best) to 100 (worst)

  26. Patient reported outcome measures- EQ-5D 3 level version (EQ-5D-3L)

    Time frame: up to 5 years

    The generic quality of life EQ-5D-3L index ranging from -0.59 (worst) to 1.00 (best)

  27. Complications

    Time frame: At 30 days, at 90 days

    Number of patients that have had complications

  28. Revision surgery

    Time frame: At 30 days, at 90 days, at 1 year

    Number of patients that have undergone revision surgeries

  29. Cost per patient

    Time frame: At 30 days, at 90 days, at 1 year

    Cost per patient

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital
  • Uppsala University

Registry information

Official study title

SpiNav - SPInal NAVigation Trial

Acronym: SPINAV

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Nov 4, 2021
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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