Clinical trial NCT05107310: The Spinal Navigation Trial - Surgical Navigation or Free Hand Technique in Spine Surgery
Official title: SpiNav - SPInal NAVigation Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Scoliosis
Kyphosis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Uppsala University
First posted: 2021-11-04
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accurately placed pedicle screws
timeFrame: Intraoperative
Secondary outcomes:
measure: Pedicle screw intraoperative revision rates-clinical assessment
timeFrame: Intraoperative
measure: Pedicle screw intraoperative revision rates- neurophysiology
timeFrame: Intraoperative
measure: Pedicle screw intraoperative revision rates- intraoperative verification
timeFrame: Intraoperative
measure: Accuracy for ARSN - path deviation in mm
timeFrame: Intraoperative
measure: Accuracy for IRSN- path deviation in mm
timeFrame: Intraoperative
measure: Accuracy for ARSN - angular deviation
timeFrame: Intraoperative
measure: Accuracy for IRSN - angular deviation
timeFrame: Intraoperative
measure: Accuracy at 1st attempt
timeFrame: Intraoperative
measure: Final accuracy of placed pedicle screws
timeFrame: Intraoperative
measure: Pedicle screw placement density
timeFrame: Intraoperative
measure: Pedicle screw placement in relation to morphometric measurements
timeFrame: Preoperative and intraoperative
measure: Deformity correction change
timeFrame: 3-6 months post-op
measure: Patient radiation dose exposure
timeFrame: Intraoperative
measure: Staff radiation dose exposure
timeFrame: Intraoperative
measure: Intraoperative characteristics- procedure time
timeFrame: Intraoperative
measure: Intraoperative characteristics- planning time
timeFrame: Intraoperative
measure: Intraoperative characteristics- instrumentation time
timeFrame: Intraoperative
measure: Intraoperative characteristics- instrumentation time/level
timeFrame: Intraoperative
measure: Intraoperative characteristics- time for verification imaging
timeFrame: Intraoperative
measure: Intraoperative characteristics- screw placement time
timeFrame: Intraoperative
measure: Intraoperative characteristics- blood loss
timeFrame: Intraoperative
measure: Inpatient stay
timeFrame: Measured from day of surgery until day of discharge. Usual length of stay is less than one week, and maximum two weeks.
measure: Patient reported outcome measures- Scoliosis Research Society 22 revised (SRS-22r)
timeFrame: up to 5 years
measure: Patient reported outcome measures- the 24 item Early Onset Scoliosis Questionnaire (EOSQ-24)
timeFrame: up to 5 years
measure: Patient reported outcome measures- Oswestry Disability Index (ODI)
timeFrame: up to 5 years
measure: Patient reported outcome measures- EQ-5D 3 level version (EQ-5D-3L)
timeFrame: up to 5 years
measure: Complications
timeFrame: At 30 days, at 90 days
measure: Revision surgery
timeFrame: At 30 days, at 90 days, at 1 year
measure: Cost per patient
timeFrame: At 30 days, at 90 days, at 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Paul Gerdhem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: