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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42432
Enrollment
43
Registered
2015-09-28
Start date
2016-04-20
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Isthmic slip

Interventions

None listed

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)