Mini-invasive Lumbar Arthrodesis in Ambulatory

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mini-invasive Lumbar Arthrodesis in Ambulatory: Pilot Study ALAMBU

Conditions
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Lumbar Spine Degeneration

Intervention / Treatment
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* Procedure: mini-invasive lumbar arthrodesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single-centre, pilot study evaluating the feasibility, difficulties and morbidity of ambulatory lumbar arthrodesis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mini-invasive lumbar arthrodesis<br>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. | Procedure: mini-invasive lumbar arthrodesis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment. | Percentage of patients with same-day discharge | within 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of ambulatory lumbar arthrodesis | Record of adverse event | through study completion, an average of 1 year | 
| Evaluate early morbidity | Occurrence of re-hospitalization and/or emergency readmission and/or need for re-operation of the patient | within 1st week | 
| Evaluate the short-term morbidity | Presence of a cicatrization disorder, the occurrence of an infection, neurological damage, adverse event related to the implants, vascular and/or medical problem. | within 1st month | 
| Evaluate the mid-term morbidity | occurrence of pseudoarthrosis | within 1st year | 
| Evaluate the patients' quality of life | Short Form-36 Health Survey questionnaire | at 1-month visit | 
| Evaluate the patients' quality of life | Evaluated by Oswestry | at 1-month visit | 
| Evaluate the patients' quality of life | Evaluated by Short Form-36 Health Survey questionnaire | at 6-month visit | 
| Evaluate the patients' quality of life | Evaluated by Oswestry | at 6-month visit | 
| Evaluate the patients' quality of life | Evaluated by Short Form-36 Health Survey questionnaire | at 1-year visit | 
| Evaluate the patients' quality of life | Evaluated by Oswestry | at 1-year visit | 
| Evaluate the patients' quality of life | Return to professional activity | at 1-month visit | 
| Evaluate the patients' quality of life | Return to professional activity | at 6-month visit | 
| Evaluate the patients' quality of life | Return to professional activity | at 1-year visit | 
| Evaluate radiological parameters | The radiological parameter: L1S1 lumbar lordosis | at 1-month visit | 
| Evaluate radiological parameters | The radiological parameter: Segmental lordosis of the arthrodesis level | at 1-month visit | 
| Evaluate radiological parameters | The radiological parameter: Pelvic Incidence | at 1-month visit | 
| Evaluate radiological parameters | The radiological parameter: Pelvic version | at 1-month visit | 
| Evaluate radiological parameters | The radiological parameter: Sacral slope | at 1-month visit | 
| Evaluate radiological parameters | The radiological parameter: Disc height | at 1-month visit | 
| Evaluate radiological parameters | The radiological parameter: L1S1 lumbar lordosis | at 6-month visit | 
| Evaluate radiological parameters | The radiological parameter: Segmental lordosis of the arthrodesis level | at 6-month visit | 
| Evaluate radiological parameters | The radiological parameter: Pelvic Incidence | at 6-month visit | 
| Evaluate radiological parameters | The radiological parameter: Pelvic version | at 6-month visit | 
| Evaluate radiological parameters | The radiological parameter: Sacral slope | at 6-month visit | 
| Evaluate radiological parameters | The radiological parameter: Disc height | at 6-month visit | 
| Evaluate radiological parameters | The radiological parameter: L1S1 lumbar lordosis | at 1-year visit | 
| Evaluate radiological parameters | The radiological parameter: Segmental lordosis of the arthrodesis level | at 1-year visit | 
| Evaluate radiological parameters | The radiological parameter: Pelvic Incidence | at 1-year visit | 
| Evaluate radiological parameters | The radiological parameter: Pelvic version | at 1-year visit | 
| Evaluate radiological parameters | The radiological parameter: Sacral slope | at 1-year visit | 
| Evaluate radiological parameters | The radiological parameter: Disc height | at 1-year visit | 
| Evaluate patient satisfaction with the procedure | Satisfaction score | at 1-month visit | 
| Evaluate patient satisfaction with the procedure | Satisfaction score | at 6-month visit | 
| Evaluate patient satisfaction with the procedure | Satisfaction score | at 1-year visit | 
| Evaluate lumbar pain | Lumbar Visual Analogue Scales pain | at 1-month visit | 
| Evaluate lumbar pain | Lumbar Visual Analogue Scales pain | at 6-month visit | 
| Evaluate lumbar pain | Lumbar Visual Analogue Scales pain | at 1-year visit | 
| Evaluate radicular pain | Radicular Visual Analogue Scales pain | at 1-month visit | 
| Evaluate radicular pain | Radicular Visual Analogue Scales pain | at 6-month visit | 
| Evaluate radicular pain | Radicular Visual Analogue Scales pain | at 1-year visit | 
| Evaluate lumbar and radicular pain | record of analgesic treatments taken before and after surgery | before the 1-month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mini-invasive lumbar arthrodesis