- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02904681
Multicenter Retrospective Evaluation of the Surgical Management of Spinal Growth Dystrophy (DRC)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Ile-de-France
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Paris, Ile-de-France, Francie, 75014
- Groupe hospitalier Paris saint Joseph
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- patients operated on for an arthrodesis Dystrophy Spinal Growth (DRC)
- Age> 10 years
- monitoring of minimum one year
Exclusion Criteria:
- deformation in the frontal plane
- kyphosis malformation
- osteoporotic or degenerative kyphosis
- post laminectomy kyphosis
- constitutional bone disease
- connective Tissue Disease
- myopathy
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Surgery complication type
Časové okno: Day 30
|
Statement from the database keops
|
Day 30
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Assessment od the clinical results based on surgical strategies
Časové okno: Day 30
|
Evaluation of clinical results based on surgical strategies. Statement from the database keops :
|
Day 30
|
|
Assessment of sagittal balance and correction Score obtained
Časové okno: Day 30
|
Evaluation of sagittal balance score obtained based surgical strategies. Statement from the database keops:
|
Day 30
|
|
Assessment of correction Score obtained
Časové okno: Day 30
|
Evaluation of sagittal correction score obtained based surgical strategies. Statement from the database keops:
|
Day 30
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- DRC
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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