Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study

NCT04134975 | Completed

• 1 other identifier: 2018-A01727-48
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators team propose to evaluate the impact of the use of intraoperative scanning coupled with Stryker navigation, compared to the conventional fluoroscopy technique, on the accuracy of pedicle screws, in instrumented spinal surgery, by a randomised prospective study, in terms of pedicular screw accuracy. We will also evaluate the radiation exposure of the neurosurgical team and the patient in these two techniques.

Conditions

Lumbar Disc Disease; Surgical Procedure, Unspecified

Keywords

spin surgery; lumbar surgery; image guided surgery; radiation exposure; intraoperative navigation

Outcome Measures

Primary Outcomes (1)

• pedicle screw positioning

  The accuracy of pedicle screw positioning will be evaluated on the early postoperative examination scan (within 48 hours after the intervention) and graded according to the following classification: * correctly positioned: pedicle screws perfectly positioned in the pedicle or with a deflection of less than 4mm. * poorly positioned: pedicle screws with a deflection greater than 4 mm.

  48 hours

Study Arms (2)

Scanner Group

EXPERIMENTAL

lumbar spine surgical procedure with guided pedicle screw placement coupled with intraoperative scanning (BODYTOM, Samsung).

Procedure: Spine surgery

fluoroscopy group

ACTIVE COMPARATOR

lumbar spinal surgery with pedicle screw placement guided by fluoroscopy, a fluoroscopic control being performed with each set screw.

Procedure: Spine surgery

Interventions

Spine surgery PROCEDURE

surgery with pedicle screw placement between L1 and S1

Scanner Group; fluoroscopy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject over the age of 18
• Subject with lumbar degenerative pathology, requiring surgery with pedicle screw placement between L1 and S1, confirmed on MRI or preoperative scan
• Well conducted medical treatment, at least 3 months, which did not allow pain sedation
• Unprotected adult within the meaning of the law
• Subject belonging to a health insurance scheme
• Subject having signed their written informed consent.

You may not qualify if:

• Subject who is a minor, pregnant, parturient or breastfeeding woman
• Adult subject under legal protection, guardianship or deprivation of liberty by judicial or administrative decision
• Subject hospitalised without consent
• Medical contraindications to surgery and anaesthesia
• Contraindication of a medical nature to an MRI (pace-maker) or a scan being carried out
• Subject already treated by surgery for the same vertebral levels or adjacent levels
• Subject with scoliosis with a Cobb angle of more than 10°.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clairval Private Hospital

Marseille, Paca, 13009, France

Location

MeSH Terms

Conditions

Intervertebral disc disease

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 22, 2019
• Study Start: October 16, 2018
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

FR (1)