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

April 22, 2025 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

375

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
        • Contact:
      • Bruges, France, 33520
        • Recruiting
        • Clinique du dos de Bordeaux -Terrefort
        • Contact:
          • Nicolas PELLET
      • Lille, France, 59037
        • Not yet recruiting
        • CHU Lille
        • Contact:
          • Henri-Arthur LEROY
      • Lyon, France, 69008
        • Not yet recruiting
        • Centre Orthopedique Santy
        • Contact:
          • Xavier CASTEL
      • Marseille, France, 13009
        • Recruiting
        • Hopital CLAIRVAL
        • Contact:
          • François-Xavier FERRACCI
      • Narbonne, France, 11108
        • Recruiting
        • CH de Narbonne
        • Contact:
          • Stanislas MAROUBY
      • Osny, France, 95520
        • Not yet recruiting
        • Centre hospitalier Privé Sainte Marie
        • Contact:
          • Robin ARVIEU
      • Pessac, France, 33600
        • Recruiting
        • Clinique du Sport
        • Contact:
          • Amélie LEGLISE
      • Saint-gregoire, France, 35760
        • Recruiting
        • Institut locomoteur de l'Ouest-Rachi
        • Contact:
          • Jonanthan LEBHAR
      • Saint-jean-de-vedas, France, 34430
        • Recruiting
        • Cabinet Orthosud Montpellier-Clinique Saint Jean
        • Contact:
          • Alexandre DHENIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

lumbar spine surgery patients with pathologies eligible for arthrodesis surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical reintervention
Time Frame: one year
rate of surgical reinterventions within the year for arthrodesis of the operated segment.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Benjamin BOUYER, PROF, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 13, 2028

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2023/60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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