NCT06950853

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Feb 2024Aug 2028

Study Start

First participant enrolled

February 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2028

Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

3.5 years

First QC Date

April 22, 2025

Last Update Submit

April 22, 2025

Conditions

Spinal StenosisSpondylolisthesis

Keywords

spinecaresurgery

Outcome Measures

Primary Outcomes (1)

  • Surgical reintervention

    rate of surgical reinterventions within the year for arthrodesis of the operated segment.

    one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

lumbar spine surgery patients with pathologies eligible for arthrodesis surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

RECRUITING

Clinique du dos de Bordeaux -Terrefort

Bruges, 33520, France

RECRUITING

CHU Lille

Lille, 59037, France

NOT YET RECRUITING

Centre orthopédique SANTY

Lyon, 69008, France

NOT YET RECRUITING

Centre orthopédique SANTY

Lyon, 69008, France

NOT YET RECRUITING

Hôpital CLAIRVAL

Marseille, 13009, France

RECRUITING

CH de Narbonne

Narbonne, 11108, France

RECRUITING

Centre hospitalier Privé Sainte Marie

Osny, 95520, France

NOT YET RECRUITING

Clinique du sport

Pessac, 33600, France

RECRUITING

Institut locomoteur de l'Ouest-Rachi

Saint-Grégoire, 35760, France

RECRUITING

Cabinet Orthosud Montpellier-Clinique Saint Jean

Saint-Jean-de-Védas, 34430, France

RECRUITING

Cabinet Orthosud Montpellier-Clinique Saint Jean

Saint-Jean-de-Védas, 34430, France

RECRUITING

Cabinet Orthosud Montpellier-Clinique Saint Jean

Saint-Jean-de-Védas, 34430, France

RECRUITING

MeSH Terms

Conditions

Spinal StenosisSpondylolisthesis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosis

Study Officials

  • Benjamin BOUYER, PROF

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin BOUYER, PROF

CONTACT

+335 56 79 87 18b.bouyer@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2025

First Posted

April 30, 2025

Study Start

February 1, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 13, 2028

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(13)