NCT03295617

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

September 25, 2017

Last Update Submit

September 25, 2017

Conditions

Keywords

spinal thoracic herniationsurgeryendoscopic approachthoracic spineminimal invasive access

Outcome Measures

Primary Outcomes (1)

  • Japanese Orthopedic Association Score

    30 minutes

Secondary Outcomes (2)

  • Frankel score

    30 minutes

  • Parietal pain measured by visual analogic scale

    30 minutes

Study Arms (1)

spinal thoracic herniation

Procedure: Thoracoscopy

Interventions

ThoracoscopyPROCEDURE

Thoracoscopy surgery

spinal thoracic herniation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Spinal Cord Diseases

Interventions

Thoracoscopy

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • David Brauge, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 28, 2017

Study Start

March 1, 2017

Primary Completion

July 30, 2017

Study Completion

July 30, 2017

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations