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Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666860
First Posted: August 16, 2012
Last Update Posted: August 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose

During the period 1989-1999, a number of patients underwent an ALIF-procedure. Anterior Lumbar Interbody Fusion procedure (ALIF) is a type of lumbar spinal fusion. The approach of the lumbar region is by incision of the abdominal wall. The intervertebral disc is removed and replaced by a bone graft. These patients form the population of this study. The goal of this study is to evaluate their current medical condition and to determine the clinical outcome.

The clinical result will be stipulated by means of standardized questionnaires (VAS-score, Oswestry low Back Pain Questionnaire and SF-36)


Condition Intervention
Anterior Lumbar Interbody Fusion Procedure Procedure: Anterior Lumbar Interbody Fusion procedure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure. [ Time Frame: Baseline ]
    The clinical result will be stipulated by means of standardized questionnaires.

  • A clinical evaluation after an Anterior Lumbar Interbody Fusion procedure. [ Time Frame: 5 years after the operation ]
    The clinical result will be stipulated by means of standardized questionnaires.


Secondary Outcome Measures:
  • Union of the vertebrae. [ Time Frame: 1 day (At the standard follow up consultation) ]
    Standard post operative X-ray.


Enrollment: 56
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anterior Lumbar Interbody Fusion procedure Procedure: Anterior Lumbar Interbody Fusion procedure

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have an Anterior Lumbar Interbody Fusion Procedure as treatment for degenerative disc disease.
Criteria

Inclusion Criteria:

  • An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666860


Locations
Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Bart Poffyn, MD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01666860     History of Changes
Other Study ID Numbers: 2010/740
First Submitted: August 14, 2012
First Posted: August 16, 2012
Last Update Posted: August 17, 2012
Last Verified: August 2012

Keywords provided by University Hospital, Ghent:
anterior lumbar interbody fusion