Mini-invasive Lumbar Arthrodesis in Ambulatory (ALAMBU)

Elsan

Status: Completed

Conditions: Lumbar Spine Degeneration

Treatments: Procedure: mini-invasive lumbar arthrodesis

Study type: Interventional

Funder types: Other

Identifiers

NCT04914728

2020-A01211-38 (Other Identifier)

ALAMBU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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/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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

mini-invasive lumbar arthrodesis

Experimental group

Description:

The patient will be admitted to the hospital on the morning of the surgery, operated on the same morning by either the posterior or anterior mini-invasive approach. The choice of the approach depends on the specificity of the pathology leading to the arthrodesis procedure and the surgeon's experience. It is the surgeon who decides this in agreement with the patient. The patient will be discharged in the evening after agreement of the anaesthetist and the surgeon.

Treatment:

Procedure: mini-invasive lumbar arthrodesis