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Multicenter Retrospective Evaluation of the Surgical Management of Spinal Growth Dystrophy (DRC)

4. september 2017 opdateret af: Groupe Hospitalier Paris Saint Joseph

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.

Studieoversigt

Detaljeret beskrivelse

objectives:

  1. Evaluation of the rate and type of complications in different age categories and surgical strategies.
  2. Evaluation of clinical results based on surgical strategies.
  3. 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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

16

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Ile-de-France
      • Paris, Ile-de-France, Frankrig, 75014
        • Groupe Hospitalier Paris Saint Joseph

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

10 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients operated on for an arthrodesis Dystrophy Spinal Growth (DRC)

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Surgery complication type
Tidsramme: Day 30
Statement from the database keops
Day 30

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment od the clinical results based on surgical strategies
Tidsramme: Day 30

Evaluation of clinical results based on surgical strategies. Statement from the database keops :

  • Worse,
  • Acceptable,
  • Good
Day 30
Assessment of sagittal balance and correction Score obtained
Tidsramme: Day 30

Evaluation of sagittal balance score obtained based surgical strategies. Statement from the database keops:

  • Worse,
  • Acceptable,
  • Good
Day 30
Assessment of correction Score obtained
Tidsramme: Day 30

Evaluation of sagittal correction score obtained based surgical strategies. Statement from the database keops:

  • Worse,
  • Acceptable,
  • Good
Day 30

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2014

Primær færdiggørelse (Faktiske)

30. januar 2015

Studieafslutning (Faktiske)

15. april 2016

Datoer for studieregistrering

Først indsendt

31. august 2016

Først indsendt, der opfyldte QC-kriterier

13. september 2016

Først opslået (Skøn)

19. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • DRC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hofteudskiftning

3
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