Acetabular FracturesDRCNCT02904681
Multicenter Retrospective Evaluation of the Surgical Management of Spinal Growth Dystrophy
An observational study of Acetabular Fractures and Hip Replacement, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Spinal growth dystrophy (CRD), also called Scheuermann's disease, corresponding to impaired vertebral structure occurring in children and adolescents with involvement of the growth cartilage causing impaired growth and kyphosis. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Acetabular Fractures, Hip Replacement
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2014to 15 Apr 2016
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated on for an arthrodesis Dystrophy Spinal Growth (DRC)
Who may be able to join
- patients operated on for an arthrodesis Dystrophy Spinal Growth (DRC)
- Age> 10 years
- monitoring of minimum one year
Who cannot join
- deformation in the frontal plane
- kyphosis malformation
- osteoporotic or degenerative kyphosis
- post laminectomy kyphosis
- constitutional bone disease
- connective Tissue Disease
- myopathy
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Spinal growth dystrophy (CRD), also called Scheuermann's disease, corresponding to impaired vertebral structure occurring in children and adolescents with involvement of the growth cartilage causing impaired growth and kyphosis.
There are forms thoracolumbar and thoracic conventional forms of DRC with variable clinical expressions; the most important being kyphosis with spinal stiffness associated with painful elements.
Read more
The radiographic definition according Sorenson is uniformisation 5 ° affecting at least three adjacent vertebrae.
Scheuermann's disease and three problems. First, the thoracic kyphosis generates back pain which may be thoracic or lumbar indirectly attributed to compensatory lordosis. Moreover disruption sagittal balance frequently causes a significant aesthetic discomfort. Finally, scalability because the curvature may increase the likelihood of degenerative lesions disc degeneration or lumbar spinal stenosis for example.
When the disease is diagnosed early, treatment is most often associated with orthopedic physiotherapy. However, for patients with active deformation, despite an orthopedic brace treatment with chronic pain, neurological deficit or for aesthetic reasons, surgical decision can be taken.
The goal of surgical treatment of DRC is a correction of the thoracic kyphosis. It goes through a spinal fusion must be released from his column stiffness in a bad position, changing the equilibrium profile and ensure that it remains in a good position.
This surgery usually requires a prior operative time (thoracic surgery to remove the intervertebral discs) and a posterior surgical time (blockage of the vertebrae together with a bone graft and osteosynthesis). Currently different surgical strategies are practiced there is no real consensus between the teams.
Read the detailed description
objectives:
- Evaluation of the rate and type of complications in different age categories and surgical strategies.
- Evaluation of clinical results based on surgical strategies.
- Evaluation of sagittal balance and correction obtained based surgical strategies
Methodology and duration of the research
This is a multicenter retrospective cohort on the assessment of surgical practices cited objectives. Also, this research is in Chapter X of the Data Protection Act and allows the collection of personal data for the purpose of evaluation of care and prevention practices with authorization request to the CNIL; the opinion of CCTIRS therefore not required in this case.
This study concerns the data of patients operated with the techniques mentioned in addition with a decline of more than 20 years.
Patients are aware of the potential use of their data in their files for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery and most recently contained in the Home booklet setting for patients.
Nature of the data collected
The data is anonymous and not identifiable (for each subject a number of inclusion is given). The name of the surgeon is also anonymized.
The data collected concern the characteristics of the patient, as well as its history, the operating data including technical, suites and possible post-operative complications and patient monitoring.
Data collection will be done on the basis KEOPS https://www.keops-spine.fr
- Conditions
- Acetabular Fractures, Hip Replacement
- Being tested
- No intervention. Observational and descriptive study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Observational and descriptive studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery complication type
Statement from the database keops
Measured: Day 30
Secondary outcomes (3)
Assessment od the clinical results based on surgical strategies
Evaluation of clinical results based on surgical strategies. Statement from the database keops :
- Worse,
- Acceptable,
- Good
Measured: Day 30
Assessment of sagittal balance and correction Score obtained
Evaluation of sagittal balance score obtained based surgical strategies. Statement from the database keops:
- Worse,
- Acceptable,
- Good
Measured: Day 30
Assessment of correction Score obtained
Evaluation of sagittal correction score obtained based surgical strategies. Statement from the database keops:
- Worse,
- Acceptable,
- Good
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start1 Dec 2014
- Primary completion30 Jan 2015
- Study completion15 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular FracturesStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904681
- Sponsor's protocol ID
- DRC
- Acronym
- DRC
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Evaluation of the Surgical Management of Spinal Growth Dystrophy
- ClinicalTrials.gov ID
- NCT02904681
- Acronym / sponsor ID
- DRC / DRC
- Conditions
- Acetabular Fractures, Hip Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 Jan 2015 (actual)
- Study completion
- 15 Apr 2016 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
Spinal growth dystrophy (CRD), also called Scheuermann's disease, corresponding to impaired vertebral structure occurring in children and adolescents with involvement of the growth cartilage causing impaired growth and kyphosis.
There are forms thoracolumbar and thoracic conventional forms of DRC with variable clinical expressions; the most important being kyphosis with spinal stiffness associated with painful elements.
The radiographic definition according Sorenson is uniformisation 5 ° affecting at least three adjacent vertebrae.
Scheuermann's disease and three problems. First, the thoracic kyphosis generates back pain which may be thoracic or lumbar indirectly attributed to compensatory lordosis. Moreover disruption sagittal balance frequently causes a significant aesthetic discomfort. Finally, scalability because the curvature may increase the likelihood of degenerative lesions disc degeneration or lumbar spinal stenosis for example.
When the disease is diagnosed early, treatment is most often associated with orthopedic physiotherapy. However, for patients with active deformation, despite an orthopedic brace treatment with chronic pain, neurological deficit or for aesthetic reasons, surgical decision can be taken.
The goal of surgical treatment of DRC is a correction of the thoracic kyphosis. It goes through a spinal fusion must be released from his column stiffness in a bad position, changing the equilibrium profile and ensure that it remains in a good position.
This surgery usually requires a prior operative time (thoracic surgery to remove the intervertebral discs) and a posterior surgical time (blockage of the vertebrae together with a bone graft and osteosynthesis). Currently different surgical strategies are practiced there is no real consensus between the teams.
Detailed description
objectives:
- Evaluation of the rate and type of complications in different age categories and surgical strategies.
- Evaluation of clinical results based on surgical strategies.
- Evaluation of sagittal balance and correction obtained based surgical strategies
Methodology and duration of the research
This is a multicenter retrospective cohort on the assessment of surgical practices cited objectives. Also, this research is in Chapter X of the Data Protection Act and allows the collection of personal data for the purpose of evaluation of care and prevention practices with authorization request to the CNIL; the opinion of CCTIRS therefore not required in this case.
This study concerns the data of patients operated with the techniques mentioned in addition with a decline of more than 20 years.
Patients are aware of the potential use of their data in their files for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery and most recently contained in the Home booklet setting for patients.
Nature of the data collected
The data is anonymous and not identifiable (for each subject a number of inclusion is given). The name of the surgeon is also anonymized.
The data collected concern the characteristics of the patient, as well as its history, the operating data including technical, suites and possible post-operative complications and patient monitoring.
Data collection will be done on the basis KEOPS https://www.keops-spine.fr
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated on for an arthrodesis Dystrophy Spinal Growth (DRC)
Key inclusion criteria (3 listed)
- patients operated on for an arthrodesis Dystrophy Spinal Growth (DRC)
- Age> 10 years
- monitoring of minimum one year
Key exclusion criteria (7 listed)
- deformation in the frontal plane
- kyphosis malformation
- osteoporotic or degenerative kyphosis
- post laminectomy kyphosis
- constitutional bone disease
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 |
|---|---|---|
| No intervention. Observational and descriptive study | Other | – |
Primary outcome
Surgery complication type
Time frame: Day 30
Statement from the database keops
3 secondary outcomes
Assessment od the clinical results based on surgical strategies
Time frame: Day 30
Assessment of sagittal balance and correction Score obtained
Time frame: Day 30
Assessment of correction Score obtained
Time frame: Day 30
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 6 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acetabular Fractures and Hip Replacement, run by Fondation Hôpital Saint-Joseph 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 3 inclusion and 7 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 6 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?
Surgery complication type (time frame: Day 30). 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 6 Sep 2017.