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

August 14, 2008
April 1, 2013
August 2008
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Complete list of historical versions of study NCT00736398 on ClinicalTrials.gov Archive Site
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Fusion Assessment Clinical Trial
Fusion Assessment Clinical Trial (FACT)

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients requiring spinal fusion

Degenerative Disc Disease
Procedure: Spinal fusion
Spinal fusion
Observation
Spinal fusion
Intervention: Procedure: Spinal fusion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
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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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00736398
01000-T02
No
Vin Jannetty / CEO, Flexuspine, Inc.
Flexuspine, Inc.
Not Provided
Not Provided
Flexuspine, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP