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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01666860
First received: August 14, 2012
Last updated: August 16, 2012
Last verified: August 2012
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666860

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

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01666860     History of Changes
Other Study ID Numbers: 2010/740
Study First Received: August 14, 2012
Last Updated: August 16, 2012
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on July 20, 2014