The Spinal Navigation Trial - Surgical Navigation or Free Hand Technique in Spine Surgery
- Conditions
- KyphosisScoliosis
- Interventions
- Procedure: Pedicle screws insertion using IRSNProcedure: Pedicle screws insertion using ARSNProcedure: Pedicle screws insertion by free hand technique
- Registration Number
- NCT05107310
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
The spinal navigation trial (SPINAV) is a randomized controlled trial (RCT) evaluating the use of computer-assisted navigation in surgery for spinal deformity
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 62
- Written informed consent by patient or legal guardian
- Age 12 years and older
- Spinal deformity surgery
- Unable to give informed consent
- Surgery without pedicle screws
- Previous surgery with pedicle screws in the planned surgical area
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Navigation group 2 IRSN Pedicle screws insertion using IRSN Infrared surgical navigation (IRSN). Pedicle screw placement using Brainlab Curve 1.2 combined with Medtronic o-arm for imaging. Navigation group 1 ARSN Pedicle screws insertion using ARSN Augmented reality surgical navigation (ARSN). Pedicle screw placement using the Philips ClarifEye system combined with Philips Allura for imaging. Control group 1 FH Pedicle screws insertion by free hand technique Free hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique. Control group 2 FH Pedicle screws insertion by free hand technique Free hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique.
- Primary Outcome Measures
Name Time Method Accurately placed pedicle screws 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 Outcome Measures
Name Time Method Pedicle screw intraoperative revision rates- intraoperative verification Intraoperative Number of screws intraoperatively revised based on intraoperative verification CBCT scan
Accuracy for ARSN - path deviation in mm Intraoperative Deviation from planned navigated path in mm at bone entry and screw tip measured on the postoperative computed tomography (CT)
Intraoperative characteristics- instrumentation time/level Intraoperative Instrumentation time normalized to number of levels
Intraoperative characteristics- time for verification imaging Intraoperative Time for intraoperative verification imaging (CBCT and/or Fluoroscopy)
Cost per patient At 30 days, at 90 days, at 1 year Cost per patient
Accuracy for ARSN - angular deviation Intraoperative Angular deviation (degrees) of the placed screw compared to the planned navigated path measured on the postoperative computed tomography (CT)
Staff radiation dose exposure Intraoperative Average staff radiation exposure (in mSv) for the whole procedure
Intraoperative characteristics- instrumentation time Intraoperative Instrumentation time (total time for navigated/FH screw placement from first to last screw placement)
Inpatient stay 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
Patient reported outcome measures- the 24 item Early Onset Scoliosis Questionnaire (EOSQ-24) up to 5 years The scoliosis specific questionnaire EOSQ-24 ranging from 0 (worst) to 100 (best)
Complications At 30 days, at 90 days Number of patients that have had complications
Pedicle screw intraoperative revision rates- neurophysiology Intraoperative Number of screws intraoperatively revised based on neurophysiology
Accuracy for IRSN - angular deviation Intraoperative Angular deviation of the placed screw compared to the navigated path measured on the postoperative computed tomography (CT)
Accuracy for IRSN- path deviation in mm Intraoperative Deviation from navigated path in mm at bone entry and screw tip measured on the postoperative computed tomography (CT)
Pedicle screw intraoperative revision rates-clinical assessment Intraoperative Number of screws intraoperatively revised based on clinical assessment
Pedicle screw placement density Intraoperative The study aims for 100% pedicle screw density. Hooks may be placed as rescue or if screw placement fails.
Pedicle screw placement in relation to morphometric measurements Preoperative and intraoperative Pedicle diameters are measured on preoperative and intraoperative CT. Pedicle screw placement measured on intraoperative and postoperative CT.
Deformity correction change 3-6 months post-op Cobb angle change from preoperative to first erect postoperative radiograph
Patient radiation dose exposure 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
Intraoperative characteristics- procedure time Intraoperative Total procedure time as well as normalized to number of spinal levels from the upper to the lower instrumented vertebra.
Intraoperative characteristics- planning time Intraoperative Intraoperative planning time (from start of planning in navigation software until last screw planned) (only when treated with ARSN or IRSN)
Patient reported outcome measures- Oswestry Disability Index (ODI) up to 5 years The back disabiliy questionnaire (ODI) ranging from 0 (best) to 100 (worst)
Patient reported outcome measures- EQ-5D 3 level version (EQ-5D-3L) up to 5 years The generic quality of life EQ-5D-3L index ranging from -0.59 (worst) to 1.00 (best)
Revision surgery At 30 days, at 90 days, at 1 year Number of patients that have undergone revision surgeries
Accuracy at 1st attempt 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 CBCTFinal accuracy of placed pedicle screws 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.
Intraoperative characteristics- screw placement time Intraoperative Screw placement time (per screw, from start with awl to screw placed)
Intraoperative characteristics- blood loss Intraoperative Intraoperative blood loss
Patient reported outcome measures- Scoliosis Research Society 22 revised (SRS-22r) up to 5 years The scoliosis specific questionnaire SRS-22r ranging from 1 (worst) to 5 (best)
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden