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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01211-38 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mini-invasive lumbar arthrodesis | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mini-invasive lumbar arthrodesis | Procedure |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis BOISSIERE, MD | Unité de Chirurgie de la Colonne Vertébrale | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de Chirurgie de la Colonne Vertébrale | Bruges | 33520 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21665125 | Background | Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002. | |
| 19478658 | Background | Peng CW, Yue WM, Poh SY, Yeo W, Tan SB. Clinical and radiological outcomes of minimally invasive versus open transforaminal lumbar interbody fusion. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1385-9. doi: 10.1097/BRS.0b013e3181a4e3be. |
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Single-centre, pilot study evaluating the feasibility, difficulties and morbidity of ambulatory lumbar arthrodesis
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|
| 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 |
| 31276851 | Background | Dietz N, Sharma M, Adams S, Alhourani A, Ugiliweneza B, Wang D, Nuno M, Drazin D, Boakye M. Enhanced Recovery After Surgery (ERAS) for Spine Surgery: A Systematic Review. World Neurosurg. 2019 Oct;130:415-426. doi: 10.1016/j.wneu.2019.06.181. Epub 2019 Jul 2. |
| 29538716 | Background | Sivaganesan A, Hirsch B, Phillips FM, McGirt MJ. Spine Surgery in the Ambulatory Surgery Center Setting: Value-Based Advancement or Safety Liability? Neurosurgery. 2018 Aug 1;83(2):159-165. doi: 10.1093/neuros/nyy057. |
| 5676831 | Background | Wiltse LL, Bateman JG, Hutchinson RH, Nelson WE. The paraspinal sacrospinalis-splitting approach to the lumbar spine. J Bone Joint Surg Am. 1968 Jul;50(5):919-26. No abstract available. |
| 5889125 | Background | Harmon PH. A simplified surgical technic for anterior lumbar diskectomy and fusion; avoidance of complications; anatomy of the retroperitoneal veins. Clin Orthop Relat Res. 1964 Nov-Dec;37:130-44. No abstract available. |
| 7775992 | Background | Perneger TV, Leplege A, Etter JF, Rougemont A. Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults. J Clin Epidemiol. 1995 Aug;48(8):1051-60. doi: 10.1016/0895-4356(94)00227-h. |
| 31075761 | Background | Hayashi K, Boissiere L, Guevara-Villazon F, Larrieu D, Nunez-Pereira S, Bourghli A, Gille O, Vital JM, Pellise F, Sanchez Perez-Grueso FJ, Kleinstuck F, Acaroglu E, Alanay A, Obeid I. Factors influencing patient satisfaction after adult scoliosis and spinal deformity surgery. J Neurosurg Spine. 2019 May 10;31(3):408-417. doi: 10.3171/2019.2.SPINE181486. Print 2019 Sep 1. |
| 26092476 | Background | Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19. |