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Fusion Assessment Clinical Trial (FACT)

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ClinicalTrials.gov Identifier: NCT00736398
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : April 4, 2013
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Degenerative Disc Disease Procedure: Spinal fusion

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fusion Assessment Clinical Trial (FACT)
Study Start Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Observation
Spinal fusion
Procedure: Spinal fusion
Spinal fusion


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring spinal fusion
Criteria

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
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): NCT00736398


Locations
United States, Florida
Florida Spine Institute
Clearwater, Florida, United States, 33765
Foundation for Orthopaedic Research and Education
Temple Terrace, Florida, United States, 33637
United States, Maryland
Greater Baltimore Medica Center
Baltimore, Maryland, United States, 21204
United States, Pennsylvania
The Washington Hospital
Washington, Pennsylvania, United States, 15301
United States, South Carolina
MUSC
Charleston, South Carolina, United States, 29425
United States, Texas
Guy Danielson, M.D.
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Flexuspine, Inc.
More Information

Responsible Party: Vin Jannetty / CEO, Flexuspine, Inc.
ClinicalTrials.gov Identifier: NCT00736398     History of Changes
Other Study ID Numbers: 01000-T02
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases