Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.
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.
Study Type
OBSERVATIONAL
Enrollment
50
decompression of neurological structures
decompression of neurological structures and spine stabilization
IRCCS Istituto Ortopedico Rizzolo
Bologna, Bologna, Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Bologna, Italy
Short Form 12
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.
Time frame: at baseline (day 0)
Short Form 12
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.
Time frame: an average of 5 days (from baseline)
Short Form 12
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.
Time frame: 1 months (day 30)
Short Form 12
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.
Time frame: 3 months (day 90)
Visual Analogue Scale
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: at baseline (day 0)
Visual Analogue Scale
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).
Time frame: an average of 5 days (from baseline)
Visual Analogue Scale
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).
Time frame: 1 months (day 30)
Visual Analogue Scale
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).
Time frame: 3 months (day 90)
Oswestry Disability Index
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.
Time frame: at baseline (day 0)
Oswestry Disability Index
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.
Time frame: an average of 5 days (from baseline)
Oswestry Disability Index
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.
Time frame: 1 months (day 30)
Oswestry Disability Index
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.
Time frame: 3 months (day 90)
EuroQol-5D
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).
Time frame: at baseline (day 0)
EuroQol-5D
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).
Time frame: an average of 5 days (from baseline)
EuroQol-5D
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).
Time frame: 1 months (day 30)
EuroQol-5D
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).
Time frame: 3 months (day 90)
Postural Balance
Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).
Time frame: at baseline (day 0)
Postural Balance
Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).
Time frame: an average of 5 days (from baseline)
Postural Balance
Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).
Time frame: 1 months (day 30)
Postural Balance
Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).
Time frame: 3 months (day 90)
Locomotor performance
Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
Time frame: at baseline (day 0)
Locomotor performance
Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
Time frame: an average of 5 days (from baseline)
Locomotor performance
Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
Time frame: 1 months (day 30)
Locomotor performance
Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
Time frame: 3 months (day 90)
Spinal mobility
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Time frame: at baseline (day 0)
Spinal mobility
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Time frame: an average of 5 days (from baseline)
Spinal mobility
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Time frame: 1 months (day 30)
Spinal mobility
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Time frame: 3 months (day 90)
Evaluation of costs
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).
Time frame: after 3 years