SOLAS® Spinal Surgery Registry

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

NuVasive

ClinicalTrials.gov Identifier:

NCT01372592

First received: March 25, 2011

Last updated: October 19, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 25, 2011
Last Updated Date	October 19, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 10, 2011)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01372592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	SOLAS® Spinal Surgery Registry
Official Title ^ICMJE	SOLAS® Spinal Surgery Registry: Prospective Clinical and Radiographic Outcomes Data Collection in Degenerative, Deformity, and Trauma Patients
Brief Summary	The SOLAS 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Vertebra; Degeneration Spinal Trauma Spinal Deformity
Intervention ^ICMJE	Procedure: Surgery Patients will receive standard of care surgical treatment dependent on his/her spinal condition.
Study Group/Cohort (s)	Degenerative Patients being treated for degenerative spine conditions. Intervention: Procedure: Surgery Deformity Patients being treated for a deformity spine condition. Intervention: Procedure: Surgery Trauma Patients being treated for a trauma related spine condition. Intervention: Procedure: Surgery
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	10000
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Candidate for spinal surgery
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01372592
Other Study ID Numbers ^ICMJE	NUVA.REG1101
Has Data Monitoring Committee	No
Responsible Party	NuVasive
Study Sponsor ^ICMJE	NuVasive
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NuVasive
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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