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Status unknownNCT04115202ECALAPUpdated Oct 3, 2019

Comparative Study of the Results of Anterior and Posterior Arthrodesis in Degenerative Lumbar Pathology

An observational study in Lumbar Arthrodesis, sponsored by Ramsay Générale de Santé. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-03.

Sponsored by Ramsay Générale de Santé · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
254
Ages
18 Years and older
Sex
All
01

Study summary

To compare the functional results through the improvement of the Oswestry medium-term score of the lumbar arthrodesis performed to treat patients with lumbago and/or lumbar-radicular pain due to degenerative lesions of the lumbar spine: degenerative disc disease, osteoarthritis spondylolisthesis or adult dislocation scoliosis.

Read the detailed description

Lower back pain is the leading cause of disability in France for adults under 45 years of age. It is also the leading cause of work stoppage and reported occupational illnesses. Thus, the degenerative pathologies of the lumbar spine can be at the origin of a severe handicap resistant to well-conducted medical treatment. This is particularly the case for degenerative disc disease, osteoarthritic spondylolisthesis and scoliotic dislocations in adults.

If lumbar arthrodesis is a recognised solution in the surgical treatment of degenerative diseases of the lumbar spine when they become disabling despite medical treatment, the choice of the operative technique and approach used to achieve it is more dependent of the training that the practitioner benefited from than the guidelines derived from published prospective comparative scientific studies comparing the results of different surgical solutions.

Our hypothesis is that the functional and radiographic results of anterior lumbar arthrodesis techniques by minimally invasive approach may differ from those of conventional posterolateral arthrodesis.

We propose to compare the results of these two surgical techniques within the orthopedic and neurosurgeon team of the Institut Parisien du Dos, mastering these two approaches optimally by leaving them free to use them as they do daily without modifying their procedures. This should allow us to judge, in a well-defined population, whether one of the two techniques is superior to the other when performed by surgeons who are experienced in this surgery.

02

Conditions studied

  • Lumbar Arthrodesis
03

In context

Lead sponsor

Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with a degenerative lumbar pathology operated

Inclusion criteria

  • Patient requiring a lumbar arthrodesis to be carried out by one of the seven investigative surgeons of the Geoffroy Saint Hilaire Clinic IPAD study.
  • At least 18 years old (no upper age limit).
  • Patient with chronic lumbago or lumbar radiculopathy and resistant to a conservative medical treatment sufficiently carried out for at least 6 months, included alongside the usual analgesic, anti-inflammatory, infiltration and rehabilitation contraindications.
  • Patient whose lumbar and/or radicular VAS is greater than or equal to 50 mm
  • Patient whose Oswestry Index is greater than or equal to 40%
  • Patient responding on one anatomical level* to one of the following diagnoses:

    • Spondylolisthesis or degenerative retrolisthesis or
    • single stage dislocation on scoliosis or
    • degenerative disc disease without true disc herniation, without deformity and instability reaching a single anatomical level
    • *single-stage pathology located between L1 and the sacrum (1 stage = 2 vertebrae and an intervertebral disc).
  • Patient with health insurance or beneficiary of a social security scheme
  • Patient having been informed of and having agreed to the use of their health data (non-opposition)

Exclusion criteria

Exclusion Criteria:

    • Any situation that is a contraindication to either surgical approach. For example, for the anterior approach: morbid obesity, a history of multiple abdomen surgical procedures, aneurysm of the operated abdominal aorta making retroperitoneal dissection dangerous, severe arteritis with risk of mobilisation of aortoiliac atheromatous plaque, previous radiotherapy (radiation in the path of the approach).
  • Contraindication to the strategy under study or an act of evaluation: for example contraindication to imagery provided (Pace maker for MRI).
  • Pathology located in L1L2 which against indicates the previous conventional approaches (need to disinsert the diaphragm).
  • Patient with proven osteoporosis: femoral T-score > -2 SD (measurement of the lumbar spine is not relevant because disturbed by osteoarthritic phenomena with vertebral osteo-condensation) and imposing a circumferential arthrodesis: anterior and posterior.
  • Patient with excluded disc herniation: hernia that cannot be removed by anterior route (NB: A simple hernia is not a non-inclusion criterion).
  • Association with the single-stage pathology another lumbar lesion imposing to extend the act of arthrodesis and/or decompression to one or more spinal stages.
  • Any situation that could interfere with the follow-up of this study, i.e. psychological instability, personal situation hindering the follow-up of the study).
  • Patient having undergone lumbar surgery less than one year ago
  • Protected patients: adults under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant, lactating or parturient women
  • Individuals hospitalised without consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
254 participants (estimated)
Patient registry
No

Groups and cohorts

  • posterior spinal approach group

    Lumbar arthrodesis performed by a posterior spinal approach.

    Procedure: lumbar arthrodesis

  • anterior spinal approach group

    Lumbar arthrodesis performed by a anterior spinal approach.

    Procedure: lumbar arthrodesis

Interventions

  • Procedurelumbar arthrodesis

    two approaches anterior versus posterior, optimally by leaving physicians free to use them as they do daily without modifying their procedures

06

What researchers measure

Primary outcomes

  1. Oswestry medium-term score

    The absolute value and improvement of the Oswestry score at 1 year compared to the preoperative score for the 2 populations of lumbar arthrodesis by anterior or posterior approach.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04115202
Lead sponsor
Ramsay Générale de Santé
Collaborators
Pr Jérome Allain
Responsible party
Sponsor
First posted
Oct 3, 2019
Start date
May 31, 2018
Primary completion
Jul 31, 2020 (estimated)
Completion
Jul 31, 2020 (estimated)
Last update
Oct 3, 2019

Study contacts

Jean Francois OUDET
Contact
jeanfrancois.oudet@free.fr
+33683346567
Marie Barba
Contact
mh.barba@ecten.eu
+330664888704 ext. +330664888704

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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