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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2029-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Scoliosis Kyphosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Navigation group 1 ARSN

Augmented reality surgical navigation (ARSN). Pedicle screw placement using the Philips ClarifEye system combined with Philips Allura for imaging.

Group Type EXPERIMENTAL

Pedicle screws insertion using ARSN

Intervention Type 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.

Control group 1 FH

Free hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique.

Group Type ACTIVE_COMPARATOR

Pedicle screws insertion by free hand technique

Intervention Type PROCEDURE

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

Navigation group 2 IRSN

Infrared surgical navigation (IRSN). Pedicle screw placement using Brainlab Curve 1.2 combined with Medtronic o-arm for imaging.

Group Type EXPERIMENTAL

Pedicle screws insertion using IRSN

Intervention Type 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.

Control group 2 FH

Free hand (FH) surgical technique. Pedicle screw placement using conventional free hand technique.

Group Type ACTIVE_COMPARATOR

Pedicle screws insertion by free hand technique

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE