Degenerative Lumbar Spinal Stenosis, Lumbar Spinal Stenosis
Conditions
Brief summary
Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.
Detailed description
Degenerative lumbar spine is the most common cause of chronic pain and disability with remarkable economic impact. Treatment begins with conservative options (physical combined with antalgic therapy) but often requires surgical treatment. Two different groups of patients affected by symptomatic lumbar stenosis with no preoperative radiological signs of instability will be recruited in a prospective trial and proposed for surgery: microsurgical decompression (MiD) or decompression and instrumented fusion (MiD + F). Clinical and mechanical outcomes of two different treatments (MiD vs. MiD+F) will be compared. An in-vitro biomechanical study will evaluate the biomechanical effect of the two surgical techniques. The aim of this project is to obtain robust data for tailoring the surgical approach to patient individual characteristics and needs, to gain the best clinical evidence, and possibly reducing the overall costs of management of this disease.
Interventions
PROCEDUREmicrosurgical decompression
decompression of neurological structures
decompression of neurological structures and spine stabilization
Sponsors
Azienda Usl di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* degenerative lumbar stenosis caused by bone hypertrophy, osteoarthritis of facet joints, ligamentous hypertrophy, disc protrusion * midsagittal spinal canal diameter of 12 mm or less * no radiological signs of instability, i.e. pathological motion on preoperative dynamic lumbar X-ray * ongoing symptoms for a minimum of 12 weeks with no improvement to conservative treatment * eligibility for decompression alone (MiD) or decompression and fusion (MiD+F)
Exclusion criteria
* congenital, traumatic, infectious and neoplastic lumbar stenosis, * spondylolisthesis (on static X-ray), lumbar scoliosis (Cobb\>10°), * previous lumbar surgery, other types of operations (endoscopic decompression, anterior interbody fusions, interspinous devices etc.). * patients with spine deformity requiring long fusion (i.e. \>=3 levels)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form 12 | at baseline (day 0) | The Short Form-12 (SF-12) healthy questionnaire is a generic standardized instrument assessing the impact of health on quality of life. It is made of twelve questions from which are calculated two different score: a Physical Component Score (with a score range 23,99 - 56,57) and a Mental Component Score (with a score range 19,06 - 60,75). The higher the number the better the outcome. |
| Visual Analogue Scale | at baseline (day 0) | The Visual Analogue Scale (VAS) is a pain rating scale, where the minimum score is 0 (no pain) and maximum score is 10 (maximum pain imaginable). |
| Oswestry Disability Index | at baseline (day 0) | The Oswestry Disability Index (ODI) is a patient-completed questionnaire which gives a percentage score, from 0% (no disability) to 100% (complete disability), of level of function (disability). It is made of ten questions and for each question there are six possible answers. |
| EuroQol-5D | at baseline (day 0) | The EuroQol-5D (EQ-5D) is an instrument for measuring quality of life. The score is based on two part. The first part includes five questions with three answers with a range from 1 (best outcome) to 3 (worst outcome). The second part consists in a numeric scale from 0 (worst outcome) to 100 (best outcome). |
| Postural Balance | at baseline (day 0) | Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available). |
| Locomotor performance | at baseline (day 0) | Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available). |
| Spinal mobility | at baseline (day 0) | Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of costs | after 3 years | The secondary outcome aims to compare the costs related to the two procedures themselfs (costs of the surgical procedure, hospital stay, blood transfusion, use of pain medications), but also the social costs related to absence from work (no min or max score available). |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORAlfredo Conti, Prof.
IRCCS Istituto delle Scienze Neurologiche di Bologna
Outcome results
None listed