Giant Thoracic HerniationGHTTNCT03295617
Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases
An observational study of Giant Thoracic Herniation and Myelopathy, run by Hopital Foch at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Giant Thoracic Herniation, Myelopathy
- What is being tested?
- Thoracoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 30 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient operated on giant thoracic thoracic disc herniation between May 2001 and October 2016
Who may be able to join
- Patient operated on giant thoracic thoracic disc herniation between May 2001 and October 2016
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Giant Thoracic Herniation, Myelopathy
- Being tested
- Thoracoscopy
- Keywords
- spinal thoracic herniation, surgery, endoscopic approach, thoracic spine, minimal invasive access
- Medical subject headings
- Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracoscopyProcedure or surgery
Thoracoscopy surgery
| Study group | Role | What they receive |
|---|---|---|
| spinal thoracic herniation | Not described Receives: Procedure: Thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Japanese Orthopedic Association Score
Measured: 30 minutes
Secondary outcomes (2)
Frankel score
Measured: 30 minutes
Parietal pain measured by visual analogic scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Mar 2017
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Thoracic HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Brauge, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295617
- Sponsor's protocol ID
- 2017/xx
- Acronym
- GHTT
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases
- ClinicalTrials.gov ID
- NCT03295617
- Acronym / sponsor ID
- GHTT / 2017/xx
- Conditions
- Giant Thoracic Herniation, Myelopathy
- Keywords
- spinal thoracic herniation, surgery, endoscopic approach, thoracic spine, minimal invasive access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spinal thoracic herniation | – | Procedure: Thoracoscopy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient operated on giant thoracic thoracic disc herniation between May 2001 and October 2016
Key inclusion criteria (1 listed)
- Patient operated on giant thoracic thoracic disc herniation between May 2001 and October 2016
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThoracoscopyThoracoscopy surgery | Procedure or surgery | spinal thoracic herniation |
Primary outcome
Japanese Orthopedic Association Score
Time frame: 30 minutes
2 secondary outcomes
Frankel score
Time frame: 30 minutes
Parietal pain measured by visual analogic scale
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Brauge, MD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Thoracic Herniation and Myelopathy, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Japanese Orthopedic Association Score (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.