Fusion Assessment Clinical Trial - Full Text View

Fusion Assessment Clinical Trial (FACT)

This study is currently recruiting participants.

Verified by Flexuspine, Inc., August 2008

Sponsored by:	Flexuspine, Inc.
Information provided by:	Flexuspine, Inc.
ClinicalTrials.gov Identifier:	NCT00736398

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

U.S. FDA Resources

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

Further study details as provided by Flexuspine, Inc.:

Biospecimen Retention: None Retained

Biospecimen Description:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736398

Contacts

Contact: Sarah Stout

508-351-8637 ext 208

sstout@boston-biomedical.com

Locations

United States, Texas
Guy Danielson, M.D.	Recruiting
Tyler, Texas, United States, 75701
Contact: Marolyn Stocks 903-363-1557

Sponsors and Collaborators

Flexuspine, Inc.

More Information

Responsible Party:	Flexuspine, Inc. ( Vin Jannetty / CEO )
Study ID Numbers:	01000-T02
Study First Received:	August 14, 2008
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00736398
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on January 14, 2009