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

Anterior Lumbar Interbody Fusion Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666860
• Other study ID #: 2010/740
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: August 16, 2012
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2012
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anterior Lumbar Interbody Fusion Procedure

Intervention

Procedure:
• Anterior Lumbar Interbody Fusion procedure

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure.	The clinical result will be stipulated by means of standardized questionnaires.	Baseline	No
Primary	A clinical evaluation after an Anterior Lumbar Interbody Fusion procedure.	The clinical result will be stipulated by means of standardized questionnaires.	5 years after the operation	No
Secondary	Union of the vertebrae.	Standard post operative X-ray.	1 day (At the standard follow up consultation)	No

External Links

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