- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03295617
Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases (GHTT)
September 25, 2017 updated by: Hopital Foch
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Suresnes, France, 92150
- Hopital Foch
-
-
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
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient operated on giant thoracic thoracic disc herniation between May 2001 and October 2016
Description
Inclusion Criteria:
- Patient operated on giant thoracic thoracic disc herniation between May 2001 and October 2016
Exclusion Criteria:
- none
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
spinal thoracic herniation
|
Thoracoscopy surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Japanese Orthopedic Association Score
Time Frame: 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Frankel score
Time Frame: 30 minutes
|
30 minutes
|
|
Parietal pain measured by visual analogic scale
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Brauge, MD, Hopital Foch
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)
March 1, 2017
Primary Completion (Actual)
July 30, 2017
Study Completion (Actual)
July 30, 2017
Study Registration Dates
First Submitted
September 25, 2017
First Submitted That Met QC Criteria
September 25, 2017
First Posted (Actual)
September 28, 2017
Study Record Updates
Last Update Posted (Actual)
September 28, 2017
Last Update Submitted That Met QC Criteria
September 25, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/xx
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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