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

Scoliosis Clinical Trial

— SPINAV  

Official title:

SpiNav - SPInal NAVigation Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05107310
• Other study ID #: SPINAV
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: June 30, 2029

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kyphosis
• Scoliosis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pedicle screw intraoperative revision rates-clinical assessment	Number of screws intraoperatively revised based on clinical assessment	Intraoperative
Secondary	Pedicle screw intraoperative revision rates- neurophysiology	Number of screws intraoperatively revised based on neurophysiology	Intraoperative
Secondary	Pedicle screw intraoperative revision rates- intraoperative verification	Number of screws intraoperatively revised based on intraoperative verification CBCT scan	Intraoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	Accuracy for IRSN - angular deviation	Angular deviation of the placed screw compared to the navigated path measured on the postoperative computed tomography (CT)	Intraoperative
Secondary	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
Secondary	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
Secondary	Pedicle screw placement density	The study aims for 100% pedicle screw density. Hooks may be placed as rescue or if screw placement fails.	Intraoperative
Secondary	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
Secondary	Deformity correction change	Cobb angle change from preoperative to first erect postoperative radiograph	3-6 months post-op
Secondary	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
Secondary	Staff radiation dose exposure	Average staff radiation exposure (in mSv) for the whole procedure	Intraoperative
Secondary	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
Secondary	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
Secondary	Intraoperative characteristics- instrumentation time	Instrumentation time (total time for navigated/FH screw placement from first to last screw placement)	Intraoperative
Secondary	Intraoperative characteristics- instrumentation time/level	Instrumentation time normalized to number of levels	Intraoperative
Secondary	Intraoperative characteristics- time for verification imaging	Time for intraoperative verification imaging (CBCT and/or Fluoroscopy)	Intraoperative
Secondary	Intraoperative characteristics- screw placement time	Screw placement time (per screw, from start with awl to screw placed)	Intraoperative
Secondary	Intraoperative characteristics- blood loss	Intraoperative blood loss	Intraoperative
Secondary	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.
Secondary	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
Secondary	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
Secondary	Patient reported outcome measures- Oswestry Disability Index (ODI)	The back disabiliy questionnaire (ODI) ranging from 0 (best) to 100 (worst)	up to 5 years
Secondary	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
Secondary	Complications	Number of patients that have had complications	At 30 days, at 90 days
Secondary	Revision surgery	Number of patients that have undergone revision surgeries	At 30 days, at 90 days, at 1 year
Secondary	Cost per patient	Cost per patient	At 30 days, at 90 days, at 1 year