Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.
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|ClinicalTrials.gov Identifier: NCT01666860|
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : August 17, 2012
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 or disease||Intervention/treatment|
|Anterior Lumbar Interbody Fusion Procedure||Procedure: Anterior Lumbar Interbody Fusion procedure|
|Study Type :||Observational|
|Actual Enrollment :||56 participants|
|Official Title:||Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||July 2011|
|Anterior Lumbar Interbody Fusion procedure||Procedure: Anterior Lumbar Interbody Fusion procedure|
- 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.
- Union of the vertebrae. [ Time Frame: 1 day (At the standard follow up consultation) ]Standard post operative X-ray.
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
|Ghent University Hospital|
|Ghent, Belgium, 9000|
|Principal Investigator:||Bart Poffyn, MD||University Hospital, Ghent|