To determine the incidence of radiological adjacent segment pathology (RASP) at 5 and 10 years after posterior and anterior fusion performed for low grade L5-S1 isthmic spondylolisthesis, and to evaluate the clinical outcome.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter is the incidence of RASP evaluated using magnetic
resonance imaging (MRI) and scored according to the Pfirrmann criteria. An MRI
of the lumbar spine will be obtained to evaluate adjacent levels for
radiological disc and facet joint degeneration. FJOA will be classified
according to Kettler and Weishaupt and the Pfirrman score will be used as a
grading system for the assessment of lumbar intervertebral disc degeneration. A
3.0 T Philips MRI scanner (Philips Medical Systems, Best, The Netherlands) is
used for radiological evaluation.
Secondary outcome
The secondary study parameters are the clinical and radiological outcomes up to
10 years postoperatively.
Clinical outcomes as scored on:
* VAS back and leg pain
* VAS satisfaction
* ODI-score
* SF-36
* EQ-5d
* Device-related complications
Radiological outcomes as scored on:
* Sagittal alignment (standing XLSWK lateral hips and full spine lateral
including hips)
Tertiary study parameter: The correlation between RASP (FJOA and lumbar
intervertebral disc degeneration) and the secondary outcome parameter CASP.
When VAS *50 and ODI *43, we will classified this as CASP.
Background summary
Specific treatment for isthmic spondylolisthesis is still not completely
clarified. The goal of surgical intervention is to achieve pain reduction by a
solid fusion between the vertebrae affected. This fusion can be achieved
through a posterior, anterior, or combined approach. Supplementary
instrumentation, decompression, or reposition of the listhesis can be
considered. The surgical approach used in the Sint Maartenskliniek is the
circumferential approach, which means a combination of an anterior interbody
fusion with posterior reduction and pedicle screws performed in two separate
procedures.
The role of sagittal alignment and the related possible benefits of reduction
(and therefore also instrumentation) of the listhesis have not been adequately
studied. Therefore it is still impossible to determine the optimum surgical
treatment technique since there is limited data concerning long term benefits
of circumferential fusion and the development of MRI proven Radiological
Adjacent Pathology (RASP) or Clinical Adjacent Pathology (CASP). This
information is immensely important, as findings could help to make the
circumferential an good an evidence-based accepted technique for the surgical
treatment of low-grade isthmic spondylolisthesis.
Study objective
To determine the incidence of radiological adjacent segment pathology (RASP) at
5 and 10 years after posterior and anterior fusion performed for low grade
L5-S1 isthmic spondylolisthesis, and to evaluate the clinical outcome.
Study design
Long term follow-up (5 and 10 years) of a prospective consecutive single
institution patient cohort who underwent a combination of an anterior interbody
fusion followed by a posterior decompression in two separate procedures.
Study burden and risks
The follow-up protocol is extended to 5 and 10 years follow-up post-operative.
The extra amount of time over the 5 years that a patient invests in the study
is about 2 times 90 minutes. Patients participating in this study will not
being barred by any additional risk. The questionnaires do not bring any extra
burden. The additional radiological assessments (full spine X-ray at 5 and 10
years follow-up) increases the total amount of radiation only slightly.
However, the total amount of radiation falls within the limits of the ICRP
(International Commission of Radiological Protection).
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
The current studie concerns a long term follow-up (5 and 10 years) of a existing prospective consecutive single institution patient cohort who underwent a circumferential fusion. ;Patients were included with:;- A single level, low-grade, isthmic spondylolisthesis between L5 and S1, qualifying for fusion of that single level
- Chronic low back pain with our without leg-pain
- Failure of conservative treatment for more than 6 months
- Age >21 years
- Signed informed consent
Exclusion criteria
- Previous attempted fusion at that lumbar level
- Metabolic bone disease
- Active systemic infection
- Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.).
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 | NL54964.048.15 |