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

Completed

• Conditions: Anterior Lumbar Interbody Fusion Procedure
• Interventions: Procedure: Anterior Lumbar Interbody Fusion procedure

• Registration Number: NCT01666860
• Lead Sponsor: University Hospital, Ghent

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-03
• Study Completion: 2011-07
• Status Verified: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Last Update Submitted: 2012-08-16
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anterior Lumbar Interbody Fusion procedure	Anterior Lumbar Interbody Fusion procedure	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Union of the vertebrae.	1 day (At the standard follow up consultation)	Standard post operative X-ray.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium