Fusion Assessment Clinical Trial (FACT)

April 1, 2013 updated by: Flexuspine, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients requiring spinal fusion

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Flexuspine, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 1, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01000-T02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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