An observational study in Spinal Disease, sponsored by DC2 Healthcare. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2014-07-11.
Sponsored by DC2 Healthcare · Observational
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.
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.
267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 108 across 87 observational studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →DC2 Healthcare is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients undergoing lumbar spinal surgery
Patients undergoing cervical spine surgery
Change in Visual Analogue Scale (VAS) from baseline at 4 weeks
Pain intensity scale taken at baseline and 4 weeks after surgery
Time frame: baseline and 4 weeks after surgery
Change in Visual Analogue Scale (VAS) from baseline at 3 months
Pain intensity scale taken at baseline and 3 months after surgery
Time frame: baseline and 3 months after surgery
Change in Visual Analogue Scale (VAS) from baseline at 6 months
Pain intensity scale taken at baseline and 6 months after surgery
Time frame: baseline and 6 months after surgery
Change in Visual Analogue Scale (VAS) from baseline at 12 months
Pain intensity scale taken at baseline and 12 months after surgery
Time frame: baseline and 12 months after surgery
Change in Visual Analogue Scale (VAS) from baseline at 24 months
Pain intensity scale taken at baseline and 24 months after surgery
Time frame: baseline and 24 months after surgery
Change from baseline in Oswestry Disability index at 4 weeks
Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 4 weeks after surgery.
Time frame: baseline and 4 weeks after surgery
Fusion at 6 months
Time frame: 6 months post-op
Length of hospital stay
Date of discharge will be recorded, an average of one to three days
Time frame: one to three days following surgery
Revision surgery within 30 days
Time frame: 30 days after surgery
Return to work
Time off of work and whether patient returned restricted or unrestricted
Time frame: 4 weeks after surgery
Return to normal/usual activity
Time between surgery and resuming normal activity for patient
Time frame: 4 weeks after surgery
Complications
Time frame: 24 hours after surgery
Change from baseline in Oswestry Disability index at 3 months
Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 3 months after surgery.
Time frame: baseline and 3 months after surgery
Change from baseline in Oswestry Disability index at 6 months
Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 6 months after surgery.
Time frame: baseline and 6 months after surgery
Change from baseline in Oswestry Disability index at 12 months
Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 12 months after surgery.
Time frame: baseline and 12 months after surgery
Change from baseline in Oswestry Disability index at 24 months
Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 24 months after surgery.
Time frame: baseline and 24 months after surgery
Return to work
Time off of work and whether patient returned restricted or unrestricted
Time frame: 3 months after surgery
Return to work
Time off of work and whether patient returned restricted or unrestricted
Time frame: 6 months after surgery
Return to work
Time off of work and whether patient returned restricted or unrestricted
Time frame: 12 months after surgery
Return to work
Time off of work and whether patient returned restricted or unrestricted
Time frame: 24 months after surgery
Return to normal/usual activity
Time between surgery and resuming normal activity for patient
Time frame: 3 months after surgery
Return to normal/usual activity
Time between surgery and resuming normal activity for patient
Time frame: 6 months after surgery
Return to normal/usual activity
Time between surgery and resuming normal activity for patient
Time frame: 12 months after surgery
Return to normal/usual activity
Time between surgery and resuming normal activity for patient
Time frame: 24 months after surgery
Complications
Time frame: 4 weeks after surgery
Complications
Time frame: 3 months after surgery
Complications
Time frame: 6 months after surgery
Complications
Time frame: 12 months after surgery
Complications
Time frame: 24 months after surgery
This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
DC2 Healthcare