Lumbar Disc DiseaseSCANRACHNCT04134975
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
A study testing Spine surgery in people with Lumbar Disc Disease and Surgical Procedure, Unspecified, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Disease, Surgical Procedure, Unspecified
- What is being tested?
- Spine surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2018to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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°.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Spine surgery
- Keywords
- spin surgery, lumbar surgery, image guided surgery, radiation exposure, intraoperative navigation
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine surgeryProcedure or surgery
surgery with pedicle screw placement between L1 and S1
| Study group | Role | What they receive |
|---|---|---|
| Scanner Group | Experimental | lumbar spine surgical procedure with guided pedicle screw placement coupled with intraoperative scanning (BODYTOM, Samsung). Receives: 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. Receives: Procedure: Spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start16 Oct 2018
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc DiseaseStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134975
- Sponsor's protocol ID
- 2018-A01727-48
- Acronym
- SCANRACH
- Status last verified
- Jul 2026
- First submitted
- 4 Oct 2019
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04134975
- Acronym / sponsor ID
- SCANRACH / 2018-A01727-48
- Keywords
- spin surgery, lumbar surgery, image guided surgery, radiation exposure, intraoperative navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scanner Group | Experimental | Procedure: Spine surgerylumbar spine surgical procedure with guided pedicle screw placement coupled with intraoperative scanning (BODYTOM, Samsung). |
| fluoroscopy group | Active comparator | Procedure: Spine surgerylumbar spinal surgery with pedicle screw placement guided by fluoroscopy, a fluoroscopic control being performed with each set screw. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spine surgerysurgery with pedicle screw placement between L1 and S1 | Procedure or surgery | Scanner Group, fluoroscopy group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spine surgery in people with Lumbar Disc Disease and Surgical Procedure, Unspecified, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pedicle screw positioning (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.