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NOC2 Spine Registry

9 juli 2014 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

10000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

  • There are no specific exclusion criteria

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Lumbar
Patients undergoing lumbar spinal surgery
Cervical
Patients undergoing cervical spine surgery

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Visual Analogue Scale (VAS) from baseline at 4 weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: baseline and 24 months after surgery
Pain intensity scale taken at baseline and 24 months after surgery
baseline and 24 months after surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Komplikationer
Tidsram: 24 timmar efter operationen
24 timmar efter operationen
Change from baseline in Oswestry Disability index at 4 weeks
Tidsram: 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
Tidsram: 6 months post-op
6 months post-op
Length of hospital stay
Tidsram: 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
Tidsram: 30 days after surgery
30 days after surgery
Return to work
Tidsram: 4 weeks after surgery
Time off of work and whether patient returned restricted or unrestricted
4 weeks after surgery
Return to normal/usual activity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 3 months after surgery
Time off of work and whether patient returned restricted or unrestricted
3 months after surgery
Return to work
Tidsram: 6 months after surgery
Time off of work and whether patient returned restricted or unrestricted
6 months after surgery
Return to work
Tidsram: 12 months after surgery
Time off of work and whether patient returned restricted or unrestricted
12 months after surgery
Return to work
Tidsram: 24 months after surgery
Time off of work and whether patient returned restricted or unrestricted
24 months after surgery
Return to normal/usual activity
Tidsram: 3 months after surgery
Time between surgery and resuming normal activity for patient
3 months after surgery
Return to normal/usual activity
Tidsram: 6 months after surgery
Time between surgery and resuming normal activity for patient
6 months after surgery
Return to normal/usual activity
Tidsram: 12 months after surgery
Time between surgery and resuming normal activity for patient
12 months after surgery
Return to normal/usual activity
Tidsram: 24 months after surgery
Time between surgery and resuming normal activity for patient
24 months after surgery
Complications
Tidsram: 4 weeks after surgery
4 weeks after surgery
Complications
Tidsram: 3 months after surgery
3 months after surgery
Complications
Tidsram: 6 months after surgery
6 months after surgery
Complications
Tidsram: 12 months after surgery
12 months after surgery
Complications
Tidsram: 24 months after surgery
24 months after surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

DC2 Healthcare

Samarbetspartners

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2011

Primärt slutförande (Förväntat)

1 december 2016

Studieregistreringsdatum

Först inskickad

9 juli 2014

Först inskickad som uppfyllde QC-kriterierna

9 juli 2014

Första postat (Uppskatta)

11 juli 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

11 juli 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 juli 2014

Senast verifierad

1 juli 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NOC 1001

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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