Recruiting

Observational Study

Sponsor:

DC2 Healthcare

Code:

NCT02187666

Conditions

Spinal Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Spinal Disease

Study ID

NCT02187666

Start date

Dec, 2011

Status verified date

Jul, 2014

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • There are no specific exclusion criteria

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Lumbar

Patients undergoing lumbar spinal surgery

Cervical

Patients undergoing cervical spine surgery

Primary outcome measure

  • Change in Visual Analogue Scale (VAS) from baseline at 4 weeks [ Time Frame: baseline and 4 weeks after surgery ]
  • Change in Visual Analogue Scale (VAS) from baseline at 3 months [ Time Frame: baseline and 3 months after surgery ]
  • Change in Visual Analogue Scale (VAS) from baseline at 6 months [ Time Frame: baseline and 6 months after surgery ]
  • Change in Visual Analogue Scale (VAS) from baseline at 12 months [ Time Frame: baseline and 12 months after surgery ]
  • Change in Visual Analogue Scale (VAS) from baseline at 24 months [ Time Frame: baseline and 24 months after surgery ]

Central Contacts and Locations

Central contacts

Christina R Cook, PhD

615-712-9574ccook@dc2healthcare.com

Risa Tyo, PharmD

615-712-9574rtyo@dc2healthcare.com

Locations

DC2 Healthcare

Recruiting

Nashville, Tennessee, United States, 37211

Contacts

Christina R Cook, PhD

615-712-9574ccook@dc2healthcare.com

Risa Tyo, PharmD

615-712-9574rtyo@dc2healthcare.com

More Information

Sponsor

DC2 Healthcare

Last update posted

Jul 11, 2014

Last verified

Jul, 2014

Keywords

  • Cervical
  • Lumbar
  • Spine
  • Spinal Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by DC2 Healthcare on 2014-07-11.