Clinical trial NCT04914728: Mini-invasive Lumbar Arthrodesis in Ambulatory
Official title: Mini-invasive Lumbar Arthrodesis in Ambulatory: Pilot Study "ALAMBU"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Degeneration
Keywords: mini-invasive lumbar arthrodesis
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-centre, pilot study evaluating the feasibility, difficulties and morbidity of ambulatory lumbar arthrodesis
Primary purpose: OTHER

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment.
timeFrame: within 24 hours after surgery
Secondary outcomes:
measure: Evaluate the safety of ambulatory lumbar arthrodesis
timeFrame: through study completion, an average of 1 year
measure: Evaluate early morbidity
timeFrame: within 1st week
measure: Evaluate the short-term morbidity
timeFrame: within 1st month
measure: Evaluate the mid-term morbidity
timeFrame: within 1st year
measure: Evaluate the patients' quality of life
timeFrame: at 1-month visit
measure: Evaluate the patients' quality of life
timeFrame: at 1-month visit
measure: Evaluate the patients' quality of life
timeFrame: at 6-month visit
measure: Evaluate the patients' quality of life
timeFrame: at 6-month visit
measure: Evaluate the patients' quality of life
timeFrame: at 1-year visit
measure: Evaluate the patients' quality of life
timeFrame: at 1-year visit
measure: Evaluate the patients' quality of life
timeFrame: at 1-month visit
measure: Evaluate the patients' quality of life
timeFrame: at 6-month visit
measure: Evaluate the patients' quality of life
timeFrame: at 1-year visit
measure: Evaluate radiological parameters
timeFrame: at 1-month visit
measure: Evaluate radiological parameters
timeFrame: at 1-month visit
measure: Evaluate radiological parameters
timeFrame: at 1-month visit
measure: Evaluate radiological parameters
timeFrame: at 1-month visit
measure: Evaluate radiological parameters
timeFrame: at 1-month visit
measure: Evaluate radiological parameters
timeFrame: at 1-month visit
measure: Evaluate radiological parameters
timeFrame: at 6-month visit
measure: Evaluate radiological parameters
timeFrame: at 6-month visit
measure: Evaluate radiological parameters
timeFrame: at 6-month visit
measure: Evaluate radiological parameters
timeFrame: at 6-month visit
measure: Evaluate radiological parameters
timeFrame: at 6-month visit
measure: Evaluate radiological parameters
timeFrame: at 6-month visit
measure: Evaluate radiological parameters
timeFrame: at 1-year visit
measure: Evaluate radiological parameters
timeFrame: at 1-year visit
measure: Evaluate radiological parameters
timeFrame: at 1-year visit
measure: Evaluate radiological parameters
timeFrame: at 1-year visit
measure: Evaluate radiological parameters
timeFrame: at 1-year visit
measure: Evaluate radiological parameters
timeFrame: at 1-year visit
measure: Evaluate patient satisfaction with the procedure
timeFrame: at 1-month visit
measure: Evaluate patient satisfaction with the procedure
timeFrame: at 6-month visit
measure: Evaluate patient satisfaction with the procedure
timeFrame: at 1-year visit
measure: Evaluate lumbar pain
timeFrame: at 1-month visit
measure: Evaluate lumbar pain
timeFrame: at 6-month visit
measure: Evaluate lumbar pain
timeFrame: at 1-year visit
measure: Evaluate radicular pain
timeFrame: at 1-month visit
measure: Evaluate radicular pain
timeFrame: at 6-month visit
measure: Evaluate radicular pain
timeFrame: at 1-year visit
measure: Evaluate lumbar and radicular pain
timeFrame: before the 1-month visit
Other outcomes:
Locations:
city: Bruges
country: France
facility: Unité de Chirurgie de la Colonne Vertébrale
Study officials:
affiliation: Unité de Chirurgie de la Colonne Vertébrale
name: Louis BOISSIERE, MD
role: PRINCIPAL_INVESTIGATOR
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