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
  Purpose

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 Intervention
Degenerative Disc Disease
Procedure: Spinal fusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fusion Assessment Clinical Trial (FACT)

Further study details as provided by Flexuspine, Inc.:

Estimated Enrollment: 50
Study Start Date: August 2008
Groups/Cohorts Assigned Interventions
Observation
Spinal fusion
Procedure: Spinal fusion
Spinal fusion

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Vin Jannetty / CEO, Flexuspine, Inc.
ClinicalTrials.gov Identifier: NCT00736398     History of Changes
Other Study ID Numbers: 01000-T02
Study First Received: August 14, 2008
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014