Mini-invasive Lumbar Arthrodesis in Ambulatory

NCT04914728 | Completed

• 2 other identifiers: ALAMBU2020-A01211-38
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Degeneration

Keywords

mini-invasive lumbar arthrodesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (41)

• Evaluate the safety of ambulatory lumbar arthrodesis

  through study completion, an average of 1 year

• Evaluate early morbidity

  within 1st week

• Evaluate the short-term morbidity

  within 1st month

• Evaluate the mid-term morbidity

  within 1st year

• Evaluate the patients' quality of life

  at 1-month visit

Study Arms (1)

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.

Procedure: mini-invasive lumbar arthrodesis

Interventions

mini-invasive lumbar arthrodesis PROCEDURE

* 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.

mini-invasive lumbar arthrodesis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Unité de Chirurgie de la Colonne Vertébrale

Bruges, 33520, France

Location

Related Publications (9)

• 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.

  PMID: 21665125 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.

  PMID: 19478658 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.

  PMID: 31276851 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.

  PMID: 29538716 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.

  PMID: 5676831 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.

  PMID: 5889125 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.

  PMID: 7775992 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.

  PMID: 31075761 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.

  PMID: 26092476 BACKGROUND

Study Officials

• Louis BOISSIERE, MD

  Unité de Chirurgie de la Colonne Vertébrale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre, pilot study evaluating the feasibility, difficulties and morbidity of ambulatory lumbar arthrodesis

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: June 7, 2021
• Study Start: September 28, 2020
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

FR (1)