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Recruiting NCT06950853

ESCAPE : Evaluation of Spinal Conservation by Endoscopic Procedures to Avoid Fusion

Observational Spinal Stenosis Spondylolisthesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Spinal Stenosis, Spondylolisthesis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Surgical reintervention [Time frame: one year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 13 centers
  • Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux — Bordeaux
  • Clinique du dos de Bordeaux -Terrefort — Bruges
  • CHU Lille — Lille
  • Centre orthopédique SANTY — Lyon
  • Centre orthopédique SANTY — Lyon
  • Hôpital CLAIRVAL — Marseille
  • CH de Narbonne — Narbonne
  • Centre hospitalier Privé Sainte Marie — Osny
  • … and 5 more centers

Identifiers

NCT: NCT06950853 · CHUBX 2023/60

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗