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

Karolinska Institute

Status: Active, not recruiting

Conditions: Scoliosis; Kyphosis

Treatments: Procedure: Pedicle screws insertion using ARSN; Procedure: Pedicle screws insertion by free hand technique; Procedure: Pedicle screws insertion using IRSN

Study type: Interventional

Funder types: Other

Identifiers

NCT05107310

SPINAV

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 4 patient groups

Navigation group 1 ARSN

Experimental group

Description:

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

Treatment:

Procedure: Pedicle screws insertion using ARSN

Control group 1 FH

Active Comparator group

Description:

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

Treatment:

Procedure: Pedicle screws insertion by free hand technique

Navigation group 2 IRSN

Experimental group

Description:

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

Treatment:

Procedure: Pedicle screws insertion using IRSN

Control group 2 FH

Active Comparator group

Description:

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

Treatment:

Procedure: Pedicle screws insertion by free hand technique