Long-term Follow-up of the Anterior Lumbar Interbody Fusi... | NCT01666860

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

NCT01666860

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Aug 17, 2012Estimated

Enrollment

56Actual

Phase

Not provided

Conditions

Anterior Lumbar Interbody Fusion Procedure

Interventions

Anterior Lumbar Interbody Fusion procedure

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Aug 14, 2012

First Submission Date that Met QC Criteria

Aug 15, 2012

First Posted Date

Aug 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2012

Last Update Posted Date

Aug 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anterior Lumbar Interbody Fusion procedure			Procedure: Anterior Lumbar Interbody Fusion procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anterior Lumbar Interbody Fusion procedure	Procedure		Anterior Lumbar Interbody Fusion procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure.	The clinical result will be stipulated by means of standardized questionnaires.	Baseline
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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bart Poffyn, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University Hospital		Ghent		9000	Belgium