Clinical trial NCT06950853: ESCAPE : Evaluation of Spinal Conservation by Endoscopic Procedures to Avoid Fusion
Official title: ESCAPE : Evaluation of Spinal Conservation by Endoscopic Procedures to Avoid Fusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Stenosis
Spondylolisthesis
Keywords: spine
care
surgery
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lumbar spine surgery patients with pathologies eligible for arthrodesis surgery

Brief summary: The recent development and expansion of endoscopic surgery has made it possible to offer an alternative to this therapeutic escalation. This method allows decompression procedures to be performed using optimized and minimally destructive surgical approaches, which contributes to preserving the physiological function of the lumbar spine and in particular its stability.

The main hypothesis of the research is that the use of endoscopic techniques for decompression of the lumbar spine allows a reduction in the indication for lumbar arthrodesis.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years old
* Patient consulting for a medical reason involving a spinal pathology in the investigating center :

Syndrome adjacent to an old lumbar arthrodesis defined on preoperative radiographs by an antero-posterior translation \> 3 mm, segmental kyphosis \> 10° or a disc height reduced by more than 50%, or on preoperative MRI by central stenosis of grade C or D of the Schizas classification or a herniated disc Grade 1 or 2 degenerative spondylolisthesis, i.e. with slippage less than 50% of the depth of the underlying vertebral body.

Lumbar stenosis complicating lumbar scoliosis defined by a deformation with rotation of the vertebral bodies on a frontal radiograph (absence of centering of the spinous process between the two pedicles of the vertebra concerned) and a Cobb angle greater than 20° or a rotational dislocation .

- Indication for spinal surgery by endoscopy

Exclusion Criteria:

* Patient under guardianship or curatorship,
* Persons deprived of liberty by judicial or administrative decision,
* Persons undergoing psychiatric treatment under duress requiring the consent of the legal representative
* Persons unable to express their consent,
* Persons under legal protection,
* Patient not affiliated to a social protection scheme.

Primary outcomes:
measure: Surgical reintervention
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
city: Bruges
country: France
facility: Clinique du dos de Bordeaux -Terrefort
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Centre orthopédique SANTY
city: Lyon
country: France
facility: Centre orthopédique SANTY
city: Marseille
country: France
facility: Hôpital CLAIRVAL
city: Narbonne
country: France
facility: CH de Narbonne
city: Osny
country: France
facility: Centre hospitalier Privé Sainte Marie
city: Pessac
country: France
facility: Clinique du sport
city: Saint-gregoire
country: France
facility: Institut locomoteur de l'Ouest-Rachi
city: Saint-jean-de-vedas
country: France
facility: Cabinet Orthosud Montpellier-Clinique Saint Jean
city: Saint-jean-de-vedas
country: France
facility: Cabinet Orthosud Montpellier-Clinique Saint Jean
city: Saint-jean-de-vedas
country: France
facility: Cabinet Orthosud Montpellier-Clinique Saint Jean
Study officials:
affiliation: University Hospital, Bordeaux
name: Benjamin BOUYER, PROF
role: PRINCIPAL_INVESTIGATOR
References: