NOC2 Spine Registry
9 juli 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Onbekend
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Verwacht)
10000
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Tennessee
-
Nashville, Tennessee, Verenigde Staten, 37211
- Werving
- DC2 Healthcare
-
Contact:
- Christina R Cook, PhD
- Telefoonnummer: 615-712-9574
- E-mail: ccook@dc2healthcare.com
-
Contact:
- Risa Tyo, PharmD
- Telefoonnummer: 615-712-9574
- E-mail: rtyo@dc2healthcare.com
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
Inclusion Criteria:
- Patients undergoing lumbar or cervical surgery
- Understand and sign informed consent
Exclusion Criteria:
- There are no specific exclusion criteria
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Lumbar
Patients undergoing lumbar spinal surgery
|
|
Cervical
Patients undergoing cervical spine surgery
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Visual Analogue Scale (VAS) from baseline at 4 weeks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: baseline and 24 months after surgery
|
Pain intensity scale taken at baseline and 24 months after surgery
|
baseline and 24 months after surgery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Complicaties
Tijdsspanne: 24 uur na de operatie
|
24 uur na de operatie
|
|
|
Change from baseline in Oswestry Disability index at 4 weeks
Tijdsspanne: 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
Tijdsspanne: 6 months post-op
|
6 months post-op
|
|
|
Length of hospital stay
Tijdsspanne: 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
Tijdsspanne: 30 days after surgery
|
30 days after surgery
|
|
|
Return to work
Tijdsspanne: 4 weeks after surgery
|
Time off of work and whether patient returned restricted or unrestricted
|
4 weeks after surgery
|
|
Return to normal/usual activity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3 months after surgery
|
Time off of work and whether patient returned restricted or unrestricted
|
3 months after surgery
|
|
Return to work
Tijdsspanne: 6 months after surgery
|
Time off of work and whether patient returned restricted or unrestricted
|
6 months after surgery
|
|
Return to work
Tijdsspanne: 12 months after surgery
|
Time off of work and whether patient returned restricted or unrestricted
|
12 months after surgery
|
|
Return to work
Tijdsspanne: 24 months after surgery
|
Time off of work and whether patient returned restricted or unrestricted
|
24 months after surgery
|
|
Return to normal/usual activity
Tijdsspanne: 3 months after surgery
|
Time between surgery and resuming normal activity for patient
|
3 months after surgery
|
|
Return to normal/usual activity
Tijdsspanne: 6 months after surgery
|
Time between surgery and resuming normal activity for patient
|
6 months after surgery
|
|
Return to normal/usual activity
Tijdsspanne: 12 months after surgery
|
Time between surgery and resuming normal activity for patient
|
12 months after surgery
|
|
Return to normal/usual activity
Tijdsspanne: 24 months after surgery
|
Time between surgery and resuming normal activity for patient
|
24 months after surgery
|
|
Complications
Tijdsspanne: 4 weeks after surgery
|
4 weeks after surgery
|
|
|
Complications
Tijdsspanne: 3 months after surgery
|
3 months after surgery
|
|
|
Complications
Tijdsspanne: 6 months after surgery
|
6 months after surgery
|
|
|
Complications
Tijdsspanne: 12 months after surgery
|
12 months after surgery
|
|
|
Complications
Tijdsspanne: 24 months after surgery
|
24 months after surgery
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2011
Primaire voltooiing (Verwacht)
1 december 2016
Studieregistratiedata
Eerst ingediend
9 juli 2014
Eerst ingediend dat voldeed aan de QC-criteria
9 juli 2014
Eerst geplaatst (Schatting)
11 juli 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
11 juli 2014
Laatste update ingediend die voldeed aan QC-criteria
9 juli 2014
Laatst geverifieerd
1 juli 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NOC 1001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .