Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Decompression
microsurgical decompression (MiD)
干预措施: microsurgical decompression (Procedure)
Fusion
decompression and instrumented fusion (MiD + F)
干预措施: decompression and instrumented fusion (Procedure)
结局指标
主要结局
Oswestry Disability Index
时间窗: 3 months (day 90)
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
时间窗: 3 months (day 90)
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).
Locomotor performance
时间窗: 3 months (day 90)
Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
Spinal mobility
时间窗: 3 months (day 90)
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Short Form 12
时间窗: 3 months (day 90)
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
时间窗: 3 months (day 90)
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).
Postural Balance
时间窗: 3 months (day 90)
Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).
Visual Analogue Scale
时间窗: 1 months (day 30)
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).
Locomotor performance
时间窗: an average of 5 days (from baseline)
Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
Locomotor performance
时间窗: 1 months (day 30)
Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
Spinal mobility
时间窗: at baseline (day 0)
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Spinal mobility
时间窗: an average of 5 days (from baseline)
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Spinal mobility
时间窗: 1 months (day 30)
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Short Form 12
时间窗: 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.
Short Form 12
时间窗: an average of 5 days (from baseline)
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.
Short Form 12
时间窗: 1 months (day 30)
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
时间窗: 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).
Visual Analogue Scale
时间窗: an average of 5 days (from baseline)
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
时间窗: 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.
Oswestry Disability Index
时间窗: an average of 5 days (from baseline)
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.
Oswestry Disability Index
时间窗: 1 months (day 30)
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
时间窗: 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).
EuroQol-5D
时间窗: an average of 5 days (from baseline)
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).
EuroQol-5D
时间窗: 1 months (day 30)
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
时间窗: at baseline (day 0)
Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).
Postural Balance
时间窗: an average of 5 days (from baseline)
Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).
Postural Balance
时间窗: 1 months (day 30)
Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).
Locomotor performance
时间窗: at baseline (day 0)
Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
次要结局
- Evaluation of costs(after 3 years)