Status:
COMPLETED
Mini-invasive Lumbar Arthrodesis in Ambulatory
Lead Sponsor:
Elsan
Conditions:
Lumbar Spine Degeneration
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Degenerative lumbar pathologies are characterised by functional impairment and the occurrence of severe chronic pain and disability Arthrodesis of the lumbar spine is a common surgery for the treatmen...
Detailed Description
Degenerative lumbar disease (DLD) is a condition of increasing frequency, affecting millions of patients worldwide. They are characterised by functional impairment and the occurrence of severe chronic...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years
- Patients affiliated to a social security system.
- Informed, dated and signed consent
- ASA 1 or 2
- Patient compliant and adhering to protocol visits
- Indication for a 1-level mini-invasive lumbar arthrodesis performed by anterior or posterior approach
- Failure of conservative treatment for more than 3 months
Exclusion
- History of lumbar arthrodesis
- Active neoplasia
- History of osteoporotic fractures of the spine
- Arthrodesis superior to 1 level
- Intolerance or contraindication to morphine treatments
- Respiratory insufficiency
- Preoperative anticoagulant treatment
- Contraindication to the ambulatory care: patient living alone at home, or at a distance from the establishment, and thus requiring a follow-up care and rehabilitation hospitalization
- Patient with a body mass index of greater than 40 kg/m².
- Patient with a fever (\>38°C)
- Suspected or known allergy or intolerance to the materials used and requiring a combination of different metals.
- Patient with a contraindication to the material used or for whom the use of the implant could interfere with their anatomical structures or expected physiological function.
- Pregnant or breastfeeding women
- Patient participating to an ongoing study that may interfere with the present study
- Patient under legal protection
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04914728
Start Date
September 28 2020
End Date
December 17 2021
Last Update
November 21 2022
Active Locations (1)
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1
Unité de Chirurgie de la Colonne Vertébrale
Bruges, France, 33520