Fusion Assessment Clinical Trial
FACT
1 other identifier
observational
50
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
August 15, 2008
CompletedApril 4, 2013
April 1, 2013
August 14, 2008
April 1, 2013
Conditions
Study Arms (1)
Observation
Spinal fusion
Interventions
Eligibility Criteria
Patients requiring spinal fusion
You may qualify if:
- Lumbar DDD
- Candidate for spinal fusion
- Provide written informed consent
You may not qualify if:
- Prior lumbar spinal fusion
- Metabolic bone disease
- Morbid obesity
- Systemic infection or active malignancy
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Flexuspine, Inc.lead
Study Sites (6)
Florida Spine Institute
Clearwater, Florida, 33765, United States
Foundation for Orthopaedic Research and Education
Temple Terrace, Florida, 33637, United States
Greater Baltimore Medica Center
Baltimore, Maryland, 21204, United States
The Washington Hospital
Washington, Pennsylvania, 15301, United States
MUSC
Charleston, South Carolina, 29425, United States
Guy Danielson, M.D.
Tyler, Texas, 75701, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 14, 2008
First Posted
August 15, 2008
Study Start
August 1, 2008
Last Updated
April 4, 2013
Record last verified: 2013-04