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

August 16, 2012 updated by: University Hospital, Ghent

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

56

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

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have an Anterior Lumbar Interbody Fusion Procedure as treatment for degenerative disc disease.

Description

Inclusion Criteria:

  • An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anterior Lumbar Interbody Fusion procedure
Procedure: Anterior Lumbar Interbody Fusion procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure.
Time Frame: Baseline
The clinical result will be stipulated by means of standardized questionnaires.
Baseline
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.
5 years after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Union of the vertebrae.
Time Frame: 1 day (At the standard follow up consultation)
Standard post operative X-ray.
1 day (At the standard follow up consultation)

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Bart Poffyn, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

November 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 16, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010/740

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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