What are the long term (follow-up more than 10 years) clinical and radiological results of ALIF with Brantigan ALIF I/F cages?
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical outcome measures
* Disability
* Quality of Life
* Pain
* Status of return to work and daily activities
Radiographic outcome measures
* Interbody fusion
Other parameters
* Secondary surgical procedures (e.g. revisions or supplemental fixations)
* Complications
Secondary outcome
not applicable
Background summary
In case of symptomatic degenerative disc disease, spondylolistheses or
spondylolysis recalcitrant to non-operative treatment modalities (e.g. physical
therapy, bed rest, anti-inflammatory medications), anterior lumbar interbody
fusion (ALIF) is considered to be an effective treatment option. Surprisingly,
however, only few studies have been published presenting data on the clinical
value of stand-alone ALIF cages. Mid-term results of a cohort of patients
surgically treated with an anterior, stand-alone carbon fiber Brantigan ALIF
I/F cage between 1993 and 2002 in Medical Centre Alkmaar were already evaluated
in 2004. As scientific evidence concerning the long term clinical result of
ALIF is lacking, the goal of the current study is to determine the long term
clinical outcome and radiographic fusion in this cohort of patients.
Study objective
What are the long term (follow-up more than 10 years) clinical and radiological
results of ALIF with Brantigan ALIF I/F cages?
Study design
Observational cross-sectional study
Study burden and risks
Included patients will visit the Medical Centre Alkmaar to undergo additional
physical and radiological examination. They will have to fill in a
questionnaire, which will take maximally 10 minutes. The time and radiation
burden for the subjects are small, and in proportion to the potential value of
the research, as no long term results of this surgical procedure are presently
known. All patients included in this study will undergo radiographic
assessment, which means four radiographs will be performed that the patient
otherwise would not have undergone. The mean radiation exposure during one
radiograph of the spine is 1,50 mSv (milliSievert). Thus, each patient is
exposed to 6,00 mSv. For comparison: yearly background radiation exposure in
the Netherlands is around 2 mSv per year.
Wilhelminalaan 12 - 038
Alkmaar 1815
NL
Wilhelminalaan 12 - 038
Alkmaar 1815
NL
Listed location countries
Age
Inclusion criteria
Participants are patients who already have participated in the study for the mid term assessment
Exclusion criteria
nvt
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL44767.094.13 |