Lumbar Spine Degeneration
Conditions
Keywords
mini-invasive lumbar arthrodesis
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.
Interventions
PROCEDUREmini-invasive lumbar arthrodesis
* The mini-invasive posterior approach is performed using a trans-muscular Wiltse approach. Pedicle screws, neurological decompression and intersomatic cage placement are performed. * The mini-invasive anterior approach is performed via a left retroperitoneal pararectal approach. After complete discectomy, an intersomatic cage stabilised by a screwed plate will be placed.
Sponsors
Elsan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single-centre, pilot study evaluating the feasibility, difficulties and morbidity of ambulatory lumbar arthrodesis
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment. | within 24 hours after surgery | Percentage of patients with same-day discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate early morbidity | within 1st week | Occurrence of re-hospitalization and/or emergency readmission and/or need for re-operation of the patient |
| Evaluate the short-term morbidity | within 1st month | Presence of a cicatrization disorder, the occurrence of an infection, neurological damage, adverse event related to the implants, vascular and/or medical problem. |
| Evaluate the mid-term morbidity | within 1st year | occurrence of pseudoarthrosis |
| Evaluate the patients' quality of life | at 1-month visit | Short Form-36 Health Survey questionnaire |
| Evaluate the safety of ambulatory lumbar arthrodesis | through study completion, an average of 1 year | Record of adverse event |
| Evaluate patient satisfaction with the procedure | at 1-month visit | Satisfaction score |
| Evaluate lumbar pain | at 1-month visit | Lumbar Visual Analogue Scales pain |
| Evaluate radicular pain | at 1-month visit | Radicular Visual Analogue Scales pain |
| Evaluate lumbar and radicular pain | before the 1-month visit | record of analgesic treatments taken before and after surgery |
| Evaluate radiological parameters | at 1-month visit | The radiological parameter: L1S1 lumbar lordosis |
Countries
France
Outcome results
None listed