Mini-invasive Lumbar Arthrodesis in Ambulatory: Pilot Study "ALAMBU"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Spine Degeneration
- Sponsor
- Elsan
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment.
Time Frame: within 24 hours after surgery
Percentage of patients with same-day discharge
Secondary Outcomes
- Evaluate the patients' quality of life(at 1-year visit)
- Evaluate radiological parameters(at 1-year visit)
- Evaluate lumbar pain(at 1-year visit)
- Evaluate early morbidity(within 1st week)
- Evaluate the short-term morbidity(within 1st month)
- Evaluate the mid-term morbidity(within 1st year)
- Evaluate radicular pain(at 1-year visit)
- Evaluate lumbar and radicular pain(before the 1-month visit)
- Evaluate the safety of ambulatory lumbar arthrodesis(through study completion, an average of 1 year)
- Evaluate patient satisfaction with the procedure(at 1-year visit)