Lumbar Spinal Stenosis Clinical Trial
— ARCHIMEDEOfficial title:
Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study
Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | February 28, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Istituto delle Scienze Neurologiche di Bologna | Bologna | |
Italy | IRCCS Istituto Ortopedico Rizzolo | Bologna |
Lead Sponsor | Collaborator |
---|---|
Azienda Usl di Bologna |
Italy,
Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Ap — View Citation
Overdevest GM, Jacobs W, Vleggeert-Lankamp C, Thome C, Gunzburg R, Peul W. Effectiveness of posterior decompression techniques compared with conventional laminectomy for lumbar stenosis. Cochrane Database Syst Rev. 2015 Mar 11;(3):CD010036. doi: 10.1002/1 — View Citation
Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization. J Neurosurg Spine. 2018 Apr;28(4):40 — View Citation
Scholler K, Alimi M, Cong GT, Christos P, Hartl R. Lumbar Spinal Stenosis Associated With Degenerative Lumbar Spondylolisthesis: A Systematic Review and Meta-analysis of Secondary Fusion Rates Following Open vs Minimally Invasive Decompression. Neurosurge — View Citation
Weiss AJ, Elixhauser A, Andrews RM. Characteristics of Operating Room Procedures in U.S. Hospitals, 2011. 2014 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Qualit — View Citation
Zaina F, Tomkins-Lane C, Carragee E, Negrini S. Surgical versus non-surgical treatment for lumbar spinal stenosis. Cochrane Database Syst Rev. 2016 Jan 29;2016(1):CD010264. doi: 10.1002/14651858.CD010264.pub2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | at baseline (day 0) | |
Primary | 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. | an average of 5 days (from baseline) | |
Primary | 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. | 1 months (day 30) | |
Primary | 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. | 3 months (day 90) | |
Primary | 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). | at baseline (day 0) | |
Primary | 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). | an average of 5 days (from baseline) | |
Primary | 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). | 1 months (day 30) | |
Primary | 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). | 3 months (day 90) | |
Primary | 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. | at baseline (day 0) | |
Primary | 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. | an average of 5 days (from baseline) | |
Primary | 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. | 1 months (day 30) | |
Primary | 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. | 3 months (day 90) | |
Primary | 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). | at baseline (day 0) | |
Primary | 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). | an average of 5 days (from baseline) | |
Primary | 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). | 1 months (day 30) | |
Primary | 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). | 3 months (day 90) | |
Primary | Postural Balance | Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available). | at baseline (day 0) | |
Primary | Postural Balance | Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available). | an average of 5 days (from baseline) | |
Primary | Postural Balance | Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available). | 1 months (day 30) | |
Primary | Postural Balance | Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available). | 3 months (day 90) | |
Primary | Locomotor performance | Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available). | at baseline (day 0) | |
Primary | Locomotor performance | Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available). | an average of 5 days (from baseline) | |
Primary | Locomotor performance | Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available). | 1 months (day 30) | |
Primary | Locomotor performance | Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available). | 3 months (day 90) | |
Primary | Spinal mobility | Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available). | at baseline (day 0) | |
Primary | Spinal mobility | Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available). | an average of 5 days (from baseline) | |
Primary | Spinal mobility | Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available). | 1 months (day 30) | |
Primary | Spinal mobility | Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available). | 3 months (day 90) | |
Secondary | 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). | after 3 years |
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