Mini-invasive Lumbar Arthrodesis in Ambulatory (ALAMBU)

Mini-invasive Lumbar Arthrodesis in Ambulatory: Pilot Study "ALAMBU"

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spine Degeneration
• Intervention / Treatment: Procedure: mini-invasive lumbar arthrodesis

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bruges, France, 33520
    • Unité de Chirurgie de la Colonne Vertébrale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Elsan
• Investigators: Principal Investigator: Louis BOISSIERE, MD, Unité de Chirurgie de la Colonne Vertébrale

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2020
• Primary Completion (ACTUAL): December 17, 2021
• Study Completion (ACTUAL): December 17, 2021

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (ACTUAL): June 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: mini-invasive lumbar arthrodesis
• Other Study ID Numbers: ALAMBU; 2020-A01211-38 (OTHER: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No