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

SpiNav - SPInal NAVigation Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Scoliosis; Kyphosis
• Intervention / Treatment: Procedure: Pedicle screws insertion using ARSN; Procedure: Pedicle screws insertion by free hand technique; Procedure: Pedicle screws insertion using IRSN

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 14186
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navigation group 1 ARSN; Augmented reality surgical navigation (ARSN). Pedicle screw placement using the Philips ClarifEye system combined with Philips Allura for imaging.	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.
Active Comparator: Control group 1 FH; Free hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique.	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.
Experimental: Navigation group 2 IRSN; Infrared surgical navigation (IRSN). Pedicle screw placement using Brainlab Curve 1.2 combined with Medtronic o-arm for imaging.	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.
Active Comparator: Control group 2 FH; Free hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accurately placed pedicle screws	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).	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pedicle screw intraoperative revision rates-clinical assessment	Number of screws intraoperatively revised based on clinical assessment	Intraoperative
Pedicle screw intraoperative revision rates- neurophysiology	Number of screws intraoperatively revised based on neurophysiology	Intraoperative
Pedicle screw intraoperative revision rates- intraoperative verification	Number of screws intraoperatively revised based on intraoperative verification CBCT scan	Intraoperative
Accuracy for ARSN - path deviation in mm	Deviation from planned navigated path in mm at bone entry and screw tip measured on the postoperative computed tomography (CT)	Intraoperative
Accuracy for IRSN- path deviation in mm	Deviation from navigated path in mm at bone entry and screw tip measured on the postoperative computed tomography (CT)	Intraoperative
Accuracy for ARSN - angular deviation	Angular deviation (degrees) of the placed screw compared to the planned navigated path measured on the postoperative computed tomography (CT)	Intraoperative
Accuracy for IRSN - angular deviation	Angular deviation of the placed screw compared to the navigated path measured on the postoperative computed tomography (CT)	Intraoperative
Accuracy at 1st attempt	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	Intraoperative
Final accuracy of placed pedicle screws	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.	Intraoperative
Pedicle screw placement density	The study aims for 100% pedicle screw density. Hooks may be placed as rescue or if screw placement fails.	Intraoperative
Pedicle screw placement in relation to morphometric measurements	Pedicle diameters are measured on preoperative and intraoperative CT. Pedicle screw placement measured on intraoperative and postoperative CT.	Preoperative and intraoperative
Deformity correction change	Cobb angle change from preoperative to first erect postoperative radiograph	3-6 months post-op
Patient radiation dose exposure	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	Intraoperative
Staff radiation dose exposure	Average staff radiation exposure (in mSv) for the whole procedure	Intraoperative
Intraoperative characteristics- procedure time	Total procedure time as well as normalized to number of spinal levels from the upper to the lower instrumented vertebra.	Intraoperative
Intraoperative characteristics- planning time	Intraoperative planning time (from start of planning in navigation software until last screw planned) (only when treated with ARSN or IRSN)	Intraoperative
Intraoperative characteristics- instrumentation time	Instrumentation time (total time for navigated/FH screw placement from first to last screw placement)	Intraoperative
Intraoperative characteristics- instrumentation time/level	Instrumentation time normalized to number of levels	Intraoperative
Intraoperative characteristics- time for verification imaging	Time for intraoperative verification imaging (CBCT and/or Fluoroscopy)	Intraoperative
Intraoperative characteristics- screw placement time	Screw placement time (per screw, from start with awl to screw placed)	Intraoperative
Intraoperative characteristics- blood loss	Intraoperative blood loss	Intraoperative
Inpatient stay	Length of hospital stay in days	Measured from day of surgery until day of discharge. Usual length of stay is less than one week, and maximum two weeks.
Patient reported outcome measures- Scoliosis Research Society 22 revised (SRS-22r)	The scoliosis specific questionnaire SRS-22r ranging from 1 (worst) to 5 (best)	up to 5 years
Patient reported outcome measures- the 24 item Early Onset Scoliosis Questionnaire (EOSQ-24)	The scoliosis specific questionnaire EOSQ-24 ranging from 0 (worst) to 100 (best)	up to 5 years
Patient reported outcome measures- Oswestry Disability Index (ODI)	The back disabiliy questionnaire (ODI) ranging from 0 (best) to 100 (worst)	up to 5 years
Patient reported outcome measures- EQ-5D 3 level version (EQ-5D-3L)	The generic quality of life EQ-5D-3L index ranging from -0.59 (worst) to 1.00 (best)	up to 5 years
Complications	Number of patients that have had complications	At 30 days, at 90 days
Revision surgery	Number of patients that have undergone revision surgeries	At 30 days, at 90 days, at 1 year
Cost per patient	Cost per patient	At 30 days, at 90 days, at 1 year

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; Uppsala University
• Investigators: Principal Investigator: Paul Gerdhem, MD, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis; Kyphosis
• Other Study ID Numbers: SPINAV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Manuscripts will be submitted for publication in peer-reviewed journals. Quality-controlled raw data as well as processed data used in publications will be made available at the time of publication.
• IPD Sharing Time Frame: The detailed protocol, including the statistical analysis plan will be submitted for publication after study start. No end date.
• IPD Sharing Access Criteria: Either as an appendix to publications, or at a repository at the Sponsor of the trial.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes