Anterior Lumbar Interbody Fusion ProcedureNCT01666860
Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.
An observational study of Anterior Lumbar Interbody Fusion Procedure, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Lumbar Interbody Fusion Procedure
- What is being tested?
- Anterior Lumbar Interbody Fusion procedure
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2010to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have an Anterior Lumbar Interbody Fusion Procedure as treatment for degenerative disc disease.
Who may be able to join
- An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Being tested
- Anterior Lumbar Interbody Fusion procedure
- Keywords
- anterior lumbar interbody fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Lumbar Interbody Fusion procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Anterior Lumbar Interbody Fusion procedure | Not described Receives: Procedure: Anterior Lumbar Interbody Fusion procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure.
The clinical result will be stipulated by means of standardized questionnaires.
Measured: Baseline
A clinical evaluation after an Anterior Lumbar Interbody Fusion procedure.
The clinical result will be stipulated by means of standardized questionnaires.
Measured: 5 years after the operation
Secondary outcomes (1)
Union of the vertebrae.
Standard post operative X-ray.
Measured: 1 day (At the standard follow up consultation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Lumbar Interbody Fusion ProcedureStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bart Poffyn, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666860
- Sponsor's protocol ID
- 2010/740
- Status last verified
- Aug 2012
- First submitted
- 14 Aug 2012
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.
- ClinicalTrials.gov ID
- NCT01666860
- Acronym / sponsor ID
- 2010/740
- Keywords
- anterior lumbar interbody fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior Lumbar Interbody Fusion procedure | – | Procedure: Anterior Lumbar Interbody Fusion procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have an Anterior Lumbar Interbody Fusion Procedure as treatment for degenerative disc disease.
Key inclusion criteria (1 listed)
- An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Lumbar Interbody Fusion procedure | Procedure or surgery | Anterior Lumbar Interbody Fusion procedure |
Primary outcome
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.
1 secondary outcome
Union of the vertebrae.
Time frame: 1 day (At the standard follow up consultation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
- Related InfoLink provided by the sponsor.
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Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Poffyn, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Lumbar Interbody Fusion Procedure, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2012.