Surgical Procedure, Unspecified Clinical Trial
— SCANRACHOfficial 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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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°. |
Country | Name | City | State |
---|---|---|---|
France | Clairval Private Hospital | Marseille | Paca |
Lead Sponsor | Collaborator |
---|---|
Ramsay Générale de Santé |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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