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CompletedNCT03295617GHTTUpdated Sep 28, 2017

Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases

An observational study in Giant Thoracic Herniation and Myelopathy, sponsored by Hopital Foch. Completed at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-09-28.

Sponsored by Hopital Foch · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
52
Ages
18 Years to 99 Years
Sex
All
01

Study summary

Introduction: Giant thoracic disc herniation is a rare condition for which surgical treatment is indicated when there are signs of spinal cord injury. To date, several surgical techniques have been described in the treatment of this condition on small patient series. The main objective is to evaluate the long-term results of a series of 53 patients treated with a minimally invasive endoscopic procedure. The secondary objective is to explain our pre-operative planning and the technical details of our procedure. METHOD: Retrospective monocentric study on a cohort of patients treated in our department. The following medical data from our database are analyzed: Morbidity of operative gesture (duration of procedure, bleeding, postoperative complications), clinical results at the last follow-up visit (thoracic Japanese Orthopedic Association (JOA) score, Frankel score, parietal pain , ability to walk, wish to carry out the same intervention again if necessary). On the radiological level, we evaluated the quality of the resection (total, subtotal, incomplete and impossible), the reappearance of a border of cerebrospinal fluid perimedullary and the presence of an intramedullary T2 hyperintense signal MRI post- operative. All these data are collected and analyzed anonymously. Expected Results: We believe we can demonstrate that thoracoscopy is a valid therapeutic option in the treatment of thoracic disc herniation responsible for spinal cord compression. This with a low morbidity given the minimally invasive nature of the approach.

02

Conditions studied

  • Giant Thoracic Herniation
  • Myelopathy

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Keywords

  • spinal thoracic herniation
  • surgery
  • endoscopic approach
  • thoracic spine
  • minimal invasive access
03

In context

Spinal Cord Diseases

170 studies on the registry are indexed under Spinal Cord Diseases; 56 are open to participants now.

This study's enrollment of 52 is below the median of 100 across 45 observational studies indexed under Spinal Cord Diseases.

Browse Spinal Cord Diseases studies →

Lead sponsor

Hopital Foch is the lead sponsor of 215 studies on the registry; 21 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient operated on giant thoracic thoracic disc herniation between May 2001 and October 2016

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Inclusion criteria

  • Patient operated on giant thoracic thoracic disc herniation between May 2001 and October 2016

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • spinal thoracic herniation

    Procedure: Thoracoscopy

Interventions

  • ProcedureThoracoscopy

    Thoracoscopy surgery

06

What researchers measure

Primary outcomes

  1. Japanese Orthopedic Association Score

    Time frame: 30 minutes

Secondary outcomes

  1. Frankel score

    Time frame: 30 minutes

  2. Parietal pain measured by visual analogic scale

    Time frame: 30 minutes

07

Study locations

1 site
  • Hopital Foch
    Suresnes, 92150, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in Jul 2017, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2017
First posted
Sep 28, 2017
StartActual
Mar 1, 2017
Primary completionActual
Jul 30, 2017
CompletionActual
Jul 30, 2017
Last update
Sep 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03295617
Lead sponsor
Hopital Foch
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Mar 1, 2017
Primary completion
Jul 30, 2017
Completion
Jul 30, 2017
Last update
Sep 28, 2017

Study contacts

David Brauge, MD
principal investigator · Hopital Foch

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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