Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2020-09-28
2021-12-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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mini-invasive lumbar arthrodesis
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.
mini-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.
Interventions
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mini-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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Elsan
OTHER
Responsible Party
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Principal Investigators
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Louis BOISSIERE, MD
Role: PRINCIPAL_INVESTIGATOR
Unité de Chirurgie de la Colonne Vertébrale
Locations
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Unité de Chirurgie de la Colonne Vertébrale
Bruges, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2020-A01211-38
Identifier Type: OTHER
Identifier Source: secondary_id
ALAMBU
Identifier Type: -
Identifier Source: org_study_id
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