Fusion Assessment Clinical Trial

NCT ID: NCT00736398

Last Updated: 2013-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Disc Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation

Spinal fusion

Spinal fusion

Intervention Type PROCEDURE

Spinal fusion

Interventions

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Spinal fusion

Spinal fusion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Flexuspine, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Flexuspine, Inc.

Locations

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Florida Spine Institute

Clearwater, Florida, United States

Site Status

Foundation for Orthopaedic Research and Education

Temple Terrace, Florida, United States

Site Status

Greater Baltimore Medica Center

Baltimore, Maryland, United States

Site Status

The Washington Hospital

Washington, Pennsylvania, United States

Site Status

MUSC

Charleston, South Carolina, United States

Site Status

Guy Danielson, M.D.

Tyler, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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01000-T02

Identifier Type: -

Identifier Source: org_study_id

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