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SpineTRACK Registry - Spinal Outcomes Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01372592
First Posted: June 14, 2011
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
NuVasive
  Purpose
The Spine TRACK Spinal Surgery Registry is a prospective multi-center observational data collection initiative, to capture clinical and radiographic outcomes in candidates for spine surgery with degenerative, deformity, and traumatic pathologies. As an observational database, there are no initial driving hypotheses, but rather data will be mined to answer unforeseen questions, but which may include broad topics such as comparative effectiveness between and among various surgical treatment options, and/or outcomes in various subgroups of patients such as defined by demographics, comorbidities, indications and symptoms, treatment variables, and/or outcome variables.

Condition Intervention
Vertebra; Degeneration Spinal Trauma Spinal Deformity Procedure: Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SpineTRACK (Translating Radiographic and Clinical Knowledge) Registry: Outcomes Data Collection in Degenerative, Deformity, and Trauma Patients

Further study details as provided by NuVasive:

Primary Outcome Measures:
  • To create a database of radiographic and clinical outcome measures of spinal surgery patients to evaluate the efficacy of various procedures for multiple diagnoses. [ Time Frame: 24 months then annually thereafter ]

Estimated Enrollment: 10000
Study Start Date: March 2011
Study Completion Date: December 6, 2016
Primary Completion Date: December 6, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Degenerative
Patients being treated for degenerative spine conditions.
Procedure: Surgery
Patients will receive standard of care surgical treatment dependent on his/her spinal condition.
Deformity
Patients being treated for a deformity spine condition.
Procedure: Surgery
Patients will receive standard of care surgical treatment dependent on his/her spinal condition.
Trauma
Patients being treated for a trauma related spine condition.
Procedure: Surgery
Patients will receive standard of care surgical treatment dependent on his/her spinal condition.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who are evaluated and scheduled to undergo surgical treatment for a spine-related condition are eligible to participate in this registry.
Criteria

Inclusion Criteria:

  • Candidate for spinal surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372592


  Show 28 Study Locations
Sponsors and Collaborators
NuVasive
Investigators
Study Director: Kelli Howell, MS NuVasive
  More Information

Additional Information:
Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT01372592     History of Changes
Other Study ID Numbers: NUVA.REG1101
First Submitted: March 25, 2011
First Posted: June 14, 2011
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Congenital Abnormalities