Status:
UNKNOWN
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
Lead Sponsor:
Ramsay Générale de Santé
Conditions:
Lumbar Disc Disease
Surgical Procedure, Unspecified
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 cou...
Eligibility Criteria
Inclusion
- 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
- 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°.
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04134975
Start Date
October 16 2018
End Date
April 30 2020
Last Update
March 11 2020
Active Locations (1)
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1
Clairval Private Hospital
Marseille, Paca, France, 13009