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NCT00736398 Clinical Trial

Fusion Assessment Clinical Trial

Degenerative Disc Disease Clinical Trial

— FACT  

Official title:
Fusion Assessment Clinical Trial (FACT)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00736398
Other study ID # 01000-T02
Secondary ID
Status Completed
Phase N/A
First received August 14, 2008
Last updated April 1, 2013
Start date August 2008

Study information
Verified date April 2013
Source Flexuspine, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Spinal fusion
Spinal fusion

Locations
Country Name City State
United States Greater Baltimore Medica Center Baltimore Maryland
United States MUSC Charleston South Carolina
United States Florida Spine Institute Clearwater Florida
United States Foundation for Orthopaedic Research and Education Temple Terrace Florida
United States Guy Danielson, M.D. Tyler Texas
United States The Washington Hospital Washington Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Flexuspine, Inc.

Country where clinical trial is conducted

United States, 

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