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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 (SCANRACH)

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ClinicalTrials.gov Identifier: NCT04134975
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Ramsay Générale de Santé

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.

Condition or disease Intervention/treatment Phase
Lumbar Disc Disease Surgical Procedure, Unspecified Procedure: Spine surgery Not Applicable

Detailed Description:

The use of pedicle screws in spinal surgery has seen a major advance in recent decades, allowing for greater biomechanical stability and higher fusion rates. In order to avoid any malposition that could cause neurological, vascular and visceral injuries and compromise this mechanical stability, imaging-guided surgical techniques have been developed. These are aimed at improving the positioning accuracy of pedicle screws to reduce these risks and improve mechanical stability and intervertebral fusion. Fluoroscopic examinations had long been the mainstay of intraoperative control imaging until the development of computer-assisted techniques. However, despite intraoperative examination, pedicle screw misalignment remains very common and even experienced surgeons can deviate screws in 5 to 20% of cases when using a standard fluoroscopic examination image. Thus, navigation techniques coupled with an intraoperative scanner, involving the acquisition of 2D images of the surgical field, have been developed. These techniques allow the neurosurgeon to navigate the spine and thus allow an improvement in the positioning accuracy of the pedicle screws. The correlate is an improvement of the safety of the procedure (reduction of complications) but also an optimisation of the biomechanical efficiency of the osteosynthesis.

With respect to the radiation emitted during navigated spinal surgery coupled with an intraoperative scan, some comparative studies have shown that the radiation rates received by the neurosurgical team and the patient were lower than the radiation rates received in conventional surgery. To date, few studies combining the analysis of the pedicular screw accuracy rate and the radiation rate transmitted to the neurosurgical team and patients have been published.

Therefore the team propose to evaluate the impact of the use of intraoperative scanning (BODYTom, Samsung) 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. The investigator team will also evaluate the radiation exposure of the neurosurgical team and the patient in these two techniques.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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 ScanRach Study
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Experimental: Scanner Group
lumbar spine surgical procedure with guided pedicle screw placement coupled with intraoperative scanning (BODYTOM, Samsung).
Procedure: Spine surgery
surgery with pedicle screw placement between L1 and S1

Active Comparator: fluoroscopy group
lumbar spinal surgery with pedicle screw placement guided by fluoroscopy, a fluoroscopic control being performed with each set screw.
Procedure: Spine surgery
surgery with pedicle screw placement between L1 and S1




Primary Outcome Measures :
  1. pedicle screw positioning [ Time Frame: 48 hours ]

    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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°.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134975


Contacts
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Contact: Jean Francois OUDET +33683346567 ext +33683346567 jf.oudet@ecten.eu
Contact: Marie Barba +330664888704 ext +330664888704 mh.barba@ecten.eu

Locations
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France
Clairval Private Hospital Recruiting
Marseille, Paca, France, 13009
Contact: Jean Francois OUDET    +33683346567 ext +33683346567    jf.oudet@ecten.eu   
Contact: Marie Barba    +330664888704 ext +330664888704    mh.barba@ecten.eu   
Sponsors and Collaborators
Ramsay Générale de Santé
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Responsible Party: Ramsay Générale de Santé
ClinicalTrials.gov Identifier: NCT04134975    
Other Study ID Numbers: 2018-A01727-48
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ramsay Générale de Santé:
spin surgery
lumbar surgery
image guided surgery
radiation exposure
intraoperative navigation