Clinical outcome and adjacent segment disease 5 and 10 years after posterior and anterior fusion for low grade isthmic spondylolisthesis

Recruiting

Conditions: Isthmic slip
slipped vertebra
10005959

Registration Number: NL-OMON42432

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 43

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.).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome parameter is the incidence of RASP evaluated using magnetic<br /><br>resonance imaging (MRI) and scored according to the Pfirrmann criteria. An MRI<br /><br>of the lumbar spine will be obtained to evaluate adjacent levels for<br /><br>radiological disc and facet joint degeneration. FJOA will be classified<br /><br>according to Kettler and Weishaupt and the Pfirrman score will be used as a<br /><br>grading system for the assessment of lumbar intervertebral disc degeneration. A<br /><br>3.0 T Philips MRI scanner (Philips Medical Systems, Best, The Netherlands) is<br /><br>used for radiological evaluation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are the clinical and radiological outcomes up to<br /><br>10 years postoperatively.<br /><br><br /><br>Clinical outcomes as scored on:<br /><br>* VAS back and leg pain<br /><br>* VAS satisfaction<br /><br>* ODI-score<br /><br>* SF-36<br /><br>* EQ-5d<br /><br>* Device-related complications<br /><br><br /><br>Radiological outcomes as scored on:<br /><br>* Sagittal alignment (standing XLSWK lateral hips and full spine lateral<br /><br>including hips)<br /><br><br /><br>Tertiary study parameter: The correlation between RASP (FJOA and lumbar<br /><br>intervertebral disc degeneration) and the secondary outcome parameter CASP.<br /><br>When VAS 50 and ODI 43, we will classified this as CASP.</p><br>