An interventional study of Instrumented posterolateral spine fusion. and Non-instrumented posterolateral spine fusion. in Spinal Stenosis, Spondylolisthesis Degenerative and Spinal Fusion, sponsored by Spine Centre of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Spine Centre of Southern Denmark · Not applicable, Interventional, and Treatment
The aim of this study is to determine, in patients with grade 1 degenerative spondylolisthesis with spinal stenosis, if decompression and lumbar spinal fusion with, or without supplementary pedicle screw fixation yields an improved patient reported outcome.
Lumbar spinal stenosis (LSS) is a common disease with a large impact on the quality of life of the patient. LSS is defined as narrowing of the spinal canal, nerve root canal or intervertebral foramina. Spinal stenosis is caused by degenerative changes in the lumbar spine, including thickening of the ligamentum flavum, osteophyte formation and disc protrusion. Pain is worse with standing upright and with exercise, and relieved with spine flexion or sitting down.
In the Wakayama Spine Study, investigators found radiographic severe spinal stenosis, defined as narrowing of more than two-thirds of the spinal canal area, in 30,4% of all patients, but only 17,5% were symptomatic.
Many of the patients suffering from LSS are pensioners, with an average age of 65 years. With current changes in demographics and the aging global population it is estimated that prevalence of LSS will increase to nearly 60% by 2025.
In a Danish epidemiological study, degenerative spondylolisthesis was found in 2,7% of men and 8,4% of women above 50 years. Every year, more than 3500 patients aged 60 and above are referred to Center of Spine Surgery Middelfart for LSS. According to the national Danish surgical spine database, DaneSpine, 7936 patients with LSS had surgery during a period from 2009-2013.
Patients suffering from LSS and instability are treated with decompression and posterolateral spinal fusion with or without instrumentation. According to DaneSpine, this group of patients showed improvements on both physical and psychological parameters. In countries outside of Scandinavia, these patients are usually treated with decompression and posterolateral spinal fusion with supplementary pedicle screw fixation. Instrumentation with pedicle screws and rods provides an internal splint, preventing motion during fusion healing. The fusion rate in non-instrumented arthrodesis is reported to be as low as 30-45% In contrast the fusion rate with instrumented arthrodesis have been reported to be above 80%. Although some studies have shown similar outcomes after decompression with or without instrumentation, long-term follow up has shown that a solid fusion improves clinical outcome.
In recent retrospective studies, the spinal sagittal balance, specifically the sagittal vertical axis (SVA) has been shown to affect the outcome of patients undergoing laminectomy. Decompression surgery has been shown to improve sagittal balance in patients with a preoperative imbalance, compared to patients treated with rehabilitation. The preoperative sagittal imbalance has not been shown to significantly affect health-related quality of life(HRQoL)outcomes although a residual imbalance after decompression is related to a poorer outcome. No prospective studies to our knowledge have compared the sagittal balance and outcomes in patients with spinal stenosis and spondylolisthesis, treated with decompression and spinal fusion with or without supplemental pedicle screw fixation.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's enrollment of 104 is above the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Spine Centre of Southern Denmark is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Decompression with concomitant non-instrumented posterolateral fusion with autologous(obtained from the decompression) and allogenic bone graft.
Procedure: Non-instrumented posterolateral spine fusion.
Decompression with concomitant instrumented posterolateral fusion with autologous(obtained from the decompression) and allogenic bone graft and supplementary pedicle screw fixation.
Procedure: Instrumented posterolateral spine fusion.
Posterolateral fusion with autologous and allogenic bone graft with supplementary pedicle screw fixation.
Also known as: Decompression on affected level
Posterolateral fusion with autologous and allogenic bone graft.
Also known as: Decompression on affected level
Oswestry Disability Index(ODI)
A disease specific measure of physical disability in an index score ranging from 0-100, 0 being the best possible outcome and 100 being the worst. Comparing the effectiveness of the two arms.
Time frame: 2 years after surgery
Achieved solid posterolateral fusion
Fine cut CT-scans, evaluated by 3 observers to determine if solid posterolateral fusion is achieved.
Time frame: CT-scans 1 year after surgery
Change in sagittal balance, effect on outcome.
Lateral scoliosis X-rays obtained pre operatively and after 1 and 2 years.
Time frame: Pre operative, 1 and 2 years after surgery
European Quality of life - 5 Dimensions (EQ-5D)
Changes in quality of life in the study groups, Obtained preoperatively, after 3 months, 1 year and 2 years. Scores range between -0.6 to 1.0 where 1 is perfect health.
Time frame: preoperative, 3, 12 and 24 months after surgery
Difference in cost-effectiveness between instrumented versus non-instrumented fusion.
Additional cost of instrumentation, incidence of revision surgery and treatment effectiveness, measured by health state utilities. Measured in Quality adjusted Life years(QaLY) and cost of surgery measured in American dollars.
Time frame: 2 years after surgery.
Zurich Claudication Questionnaire
Disease specific patient reported outcome, to measure changes in function. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability.
Time frame: Preoperative, 1 and 2 years after surgery.
NRS score for leg- and back pain.
Patient reported leg and back pain. Obtained preoperatively, after 3 months, 1 year and 2 years. Score is 0-100, the score increases with worsening pain.
Time frame: Properative, 1 and 2 years after surgery.
Plan to share: Yes — All individual patient data that underlies the results reported in this article, after deidentification. (texts, tables, figures)
Supporting information: Study protocol
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Spine Centre of Southern Denmark