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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

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 22, 2019
Last Update Posted Date March 11, 2020
Actual Study Start Date  ICMJE October 16, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Lumbar Disc Disease
  • Surgical Procedure, Unspecified
Intervention  ICMJE Procedure: Spine surgery
surgery with pedicle screw placement between L1 and S1
Study Arms  ICMJE
  • Experimental: Scanner Group
    lumbar spine surgical procedure with guided pedicle screw placement coupled with intraoperative scanning (BODYTOM, Samsung).
    Intervention: Procedure: Spine surgery
  • Active Comparator: fluoroscopy group
    lumbar spinal surgery with pedicle screw placement guided by fluoroscopy, a fluoroscopic control being performed with each set screw.
    Intervention: Procedure: Spine surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 21, 2019)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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°.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean Francois OUDET +33683346567 ext +33683346567 jf.oudet@ecten.eu
Contact: Marie Barba +330664888704 ext +330664888704 mh.barba@ecten.eu
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04134975
Other Study ID Numbers  ICMJE 2018-A01727-48
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ramsay Générale de Santé
Study Sponsor  ICMJE Ramsay Générale de Santé
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ramsay Générale de Santé
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP