Mini-invasive Lumbar Arthrodesis in Ambulatory

  • STATUS
    Recruiting
  • End date
    Dec 10, 2022
  • participants needed
    30
  • sponsor
    Elsan
Updated on 10 October 2021

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 treatment of degenerative lumbar pathologies. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The development of mini-invasive techniques and the development of the Improved Rehabilitation after Surgery programmes, has considerably reduced the hospital stay of the patients. It is possible that in the future mini-invasive lumbar arthrodesis will be performed on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated.

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 pain and disability.

Arthrodesis of the lumbar spine is a common surgery for the treatment of DLD. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The advent of mini-invasive techniques and the development of Improved Rehabilitation after Surgery program has made it possible to considerably reduce the duration of hospitalization of patients with a high rate of satisfaction, a reduction in costs and without increasing morbidity. In spinal surgery, decompression procedures such as discectomy and lumbar recalibration are frequently performed on an ambulatory. The first American studies with a low level of evidence on the management of mini-invasive lumbar arthrodesis are beginning to appear. It is quite possible that in the future this type of procedure will be carried out on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated. In the United States, 23-hour hospitalizations are considered as ambulatory procedures, whereas in France, ambulatory is qualified as such when the patient is admitted and discharged in the same day.

The study population was patients who had failed medical treatment (analgesics and rehabilitation) for more than three months and who required a mono-segmental arthrodesis procedure for the management of their lumbar-radiculalgia.

Details
Condition Lumbar Spine Degeneration
Treatment mini-invasive lumbar arthrodesis
Clinical Study IdentifierNCT04914728
SponsorElsan
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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/m
Patient with a fever (>38C)
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
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