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NOC2 Spine Registry

9. juli 2014 opdateret af: DC2 Healthcare

National Neurosurgical and Orthopedic Optimum Care Continuum Spine Registry Exposure for Various Implants/Products

The primary objective of the Spine Registry is to enhance the understanding of spinal disease and treatment of spinal disease with the goal of guiding treatment options.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

This study will enhance the understanding of the variability, progression and treatment of spinal disease with the ultimate goal of better guiding and assessing therapeutic intervention. Researchers will collect complications and safety following cervical and lumbar surgeries to determine best options for patients. Prospective reports will be collected on patients undergoing lumbar or cervical spinal surgery. Patients will be enrolled in registry after signing informed consent. Data will be collected at various time points. The registry will serve as a database of cervical and lumbar surgeries in which retrospective analysis and exploratory analysis of specific research questions can be answered.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

10000

Kontakter og lokationer

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

Studiesteder

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Approximately 10,000 patients undergoing lumbar or cervical surgery will be screened to decide whether they meet the inclusion and exclusion criteria of the study/patient registry. Patients who meet the study criteria will be informed by the investigator and should read the 'patient information' document. Patients must give their written informed consent to be enrolled into this study.

Beskrivelse

Inclusion Criteria:

  • Patients undergoing lumbar or cervical surgery
  • Understand and sign informed consent

Exclusion Criteria:

  • There are no specific exclusion criteria

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Lumbar
Patients undergoing lumbar spinal surgery
Cervical
Patients undergoing cervical spine surgery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Visual Analogue Scale (VAS) from baseline at 4 weeks
Tidsramme: baseline and 4 weeks after surgery
Pain intensity scale taken at baseline and 4 weeks after surgery
baseline and 4 weeks after surgery
Change in Visual Analogue Scale (VAS) from baseline at 3 months
Tidsramme: baseline and 3 months after surgery
Pain intensity scale taken at baseline and 3 months after surgery
baseline and 3 months after surgery
Change in Visual Analogue Scale (VAS) from baseline at 6 months
Tidsramme: baseline and 6 months after surgery
Pain intensity scale taken at baseline and 6 months after surgery
baseline and 6 months after surgery
Change in Visual Analogue Scale (VAS) from baseline at 12 months
Tidsramme: baseline and 12 months after surgery
Pain intensity scale taken at baseline and 12 months after surgery
baseline and 12 months after surgery
Change in Visual Analogue Scale (VAS) from baseline at 24 months
Tidsramme: baseline and 24 months after surgery
Pain intensity scale taken at baseline and 24 months after surgery
baseline and 24 months after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Komplikationer
Tidsramme: 24 timer efter operationen
24 timer efter operationen
Change from baseline in Oswestry Disability index at 4 weeks
Tidsramme: baseline and 4 weeks after surgery
Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 4 weeks after surgery.
baseline and 4 weeks after surgery
Fusion at 6 months
Tidsramme: 6 months post-op
6 months post-op
Length of hospital stay
Tidsramme: one to three days following surgery
Date of discharge will be recorded, an average of one to three days
one to three days following surgery
Revision surgery within 30 days
Tidsramme: 30 days after surgery
30 days after surgery
Return to work
Tidsramme: 4 weeks after surgery
Time off of work and whether patient returned restricted or unrestricted
4 weeks after surgery
Return to normal/usual activity
Tidsramme: 4 weeks after surgery
Time between surgery and resuming normal activity for patient
4 weeks after surgery
Change from baseline in Oswestry Disability index at 3 months
Tidsramme: baseline and 3 months after surgery
Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 3 months after surgery.
baseline and 3 months after surgery
Change from baseline in Oswestry Disability index at 6 months
Tidsramme: baseline and 6 months after surgery
Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 6 months after surgery.
baseline and 6 months after surgery
Change from baseline in Oswestry Disability index at 12 months
Tidsramme: baseline and 12 months after surgery
Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 12 months after surgery.
baseline and 12 months after surgery
Change from baseline in Oswestry Disability index at 24 months
Tidsramme: baseline and 24 months after surgery
Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 24 months after surgery.
baseline and 24 months after surgery
Return to work
Tidsramme: 3 months after surgery
Time off of work and whether patient returned restricted or unrestricted
3 months after surgery
Return to work
Tidsramme: 6 months after surgery
Time off of work and whether patient returned restricted or unrestricted
6 months after surgery
Return to work
Tidsramme: 12 months after surgery
Time off of work and whether patient returned restricted or unrestricted
12 months after surgery
Return to work
Tidsramme: 24 months after surgery
Time off of work and whether patient returned restricted or unrestricted
24 months after surgery
Return to normal/usual activity
Tidsramme: 3 months after surgery
Time between surgery and resuming normal activity for patient
3 months after surgery
Return to normal/usual activity
Tidsramme: 6 months after surgery
Time between surgery and resuming normal activity for patient
6 months after surgery
Return to normal/usual activity
Tidsramme: 12 months after surgery
Time between surgery and resuming normal activity for patient
12 months after surgery
Return to normal/usual activity
Tidsramme: 24 months after surgery
Time between surgery and resuming normal activity for patient
24 months after surgery
Complications
Tidsramme: 4 weeks after surgery
4 weeks after surgery
Complications
Tidsramme: 3 months after surgery
3 months after surgery
Complications
Tidsramme: 6 months after surgery
6 months after surgery
Complications
Tidsramme: 12 months after surgery
12 months after surgery
Complications
Tidsramme: 24 months after surgery
24 months after surgery

Samarbejdspartnere og efterforskere

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

Sponsor

DC2 Healthcare

Samarbejdspartnere

National Research Independent Operations Management
National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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

1. december 2011

Primær færdiggørelse (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

9. juli 2014

Først indsendt, der opfyldte QC-kriterier

9. juli 2014

Først opslået (Skøn)

11. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NOC 1001

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 .

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner