Fusion Assessment Clinical Trial (FACT)

This study has been completed.

Sponsor:

Information provided by:

Flexuspine, Inc.

ClinicalTrials.gov Identifier:

NCT00736398

First received: August 14, 2008

Last updated: April 1, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	August 14, 2008
Last Updated Date	April 1, 2013
Start Date ^ICMJE	August 2008
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00736398 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	Fusion Assessment Clinical Trial
Official Title ^ICMJE	Fusion Assessment Clinical Trial (FACT)
Brief Summary	This is an observational study to assess clinical outcomes in patients who undergo spinal fusion. Patients who are already scheduled for spinal fusion will enroll in the study. Information about prior therapies will be collected, and then patients will be followed to see how they do after spinal fusion. This study will help researchers better understand the natural course of patients who patients who undergo spinal fusion surgery.
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	Non-Probability Sample
Study Population	Patients requiring spinal fusion
Condition ^ICMJE	Degenerative Disc Disease
Intervention ^ICMJE	Procedure: Spinal fusion Spinal fusion
Study Group/Cohort (s)	Observation Spinal fusion Intervention: Procedure: Spinal fusion
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	Completed
Estimated Enrollment ^ICMJE	50
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Lumbar DDD Candidate for spinal fusion Provide written informed consent Exclusion Criteria: Prior lumbar spinal fusion Metabolic bone disease Morbid obesity Systemic infection or active malignancy Pregnancy
Gender	Both
Ages	30 Years and older
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	NCT00736398
Other Study ID Numbers ^ICMJE	01000-T02
Has Data Monitoring Committee	No
Responsible Party	Vin Jannetty / CEO, Flexuspine, Inc.
Study Sponsor ^ICMJE	Flexuspine, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Flexuspine, Inc.
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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