Lumbar Spinal StenosisARCHIMEDENCT06335511
Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study
An observational study of Lumbar Spinal Stenosis and Degenerative Lumbar Spinal Stenosis, run by Azienda Usl di Bologna at 2 sites in Italy.
Trial summary
Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Degenerative Lumbar Spinal Stenosis
- What is being tested?
- microsurgical decompression and decompression and instrumented fusion
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 10 Oct 2022to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult (>18yrs-old) patients with symptomatic degenerative lumbar stenosis.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Istituto Ortopedico Rizzolo
Bologna, Bologna, 40136
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Bologna, 40139
About this study
Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.
Read the 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.
- Being tested
- microsurgical decompression, decompression and instrumented fusion
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microsurgical decompressionProcedure or surgery
Also called decompression
decompression of neurological structures
decompression and instrumented fusionProcedure or surgery
Also called stabilization
decompression of neurological structures and spine stabilization
| Study group | Role | What they receive |
|---|---|---|
| Decompression | microsurgical decompression (MiD) Receives: Procedure: microsurgical decompression | |
| Fusion | decompression and instrumented fusion (MiD + F) Receives: Procedure: decompression and instrumented fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 3 months (day 90)
Spinal mobility
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Measured: at baseline (day 0)
Spinal mobility
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Measured: 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).
Measured: 1 months (day 30)
Spinal mobility
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Measured: 3 months (day 90)
Secondary outcomes (1)
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).
Measured: after 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start10 Oct 2022
- Primary completion15 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alfredo Conti, Prof., Principal investigator, IRCCS Istituto delle Scienze Neurologiche di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335511
- Sponsor's protocol ID
- 631-2021-OSS-AUSLBO
- Acronym
- ARCHIMEDE
- Status last verified
- Jul 2025
- First submitted
- 13 Mar 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26824399Scholler 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. Neurosurgery. 2017 Mar 1;80(3):355-367. doi: 10.1093/neuros/nyw091.
PubMed 28362963Ghogawala 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 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.
PubMed 27074067Overdevest 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;2015(3):CD010036. doi: 10.1002/14651858.CD010036.pub2.
PubMed 25760812Schmidt 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):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.
PubMed 29372860Weiss 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 Quality (US); 2006 Feb-. Statistical Brief #170. Available from http://www.ncbi.nlm.nih.gov/books/NBK195245/
PubMed 24716251
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study
- ClinicalTrials.gov ID
- NCT06335511
- Acronym / sponsor ID
- ARCHIMEDE / 631-2021-OSS-AUSLBO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompression | – | Procedure: microsurgical decompressionmicrosurgical decompression (MiD) |
| Fusion | – | Procedure: decompression and instrumented fusiondecompression and instrumented fusion (MiD + F) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult (>18yrs-old) patients with symptomatic degenerative lumbar stenosis.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microsurgical decompressionAlso: decompressiondecompression of neurological structures | Procedure or surgery | Decompression |
| decompression and instrumented fusionAlso: stabilizationdecompression of neurological structures and spine stabilization | Procedure or surgery | Fusion |
Primary outcome
Short Form 12
Time frame: 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
Time frame: 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
Time frame: 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.
Short Form 12
Time frame: 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
Time frame: 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
Time frame: 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).
Visual Analogue Scale
Time frame: 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).
Visual Analogue Scale
Time frame: 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).
Oswestry Disability Index
Time frame: 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
Time frame: 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
Time frame: 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.
Oswestry Disability Index
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
EuroQol-5D
Time frame: 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).
Postural Balance
Time frame: 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
Time frame: 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
Time frame: 1 months (day 30)
Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).
Postural Balance
Time frame: 3 months (day 90)
Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).
Locomotor performance
Time frame: at baseline (day 0)
Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
Locomotor performance
Time frame: 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
Time frame: 1 months (day 30)
Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
Locomotor performance
Time frame: 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
Time frame: at baseline (day 0)
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Spinal mobility
Time frame: 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
Time frame: 1 months (day 30)
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Spinal mobility
Time frame: 3 months (day 90)
Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
1 secondary outcome
Evaluation of costs
Time frame: after 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Results publication: PubMed 26824399Zaina 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.
- Results publication: PubMed 28362963Scholler 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. Neurosurgery. 2017 Mar 1;80(3):355-367. doi: 10.1093/neuros/nyw091.
- Results publication: PubMed 27074067Ghogawala 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 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.
- Results publication: PubMed 25760812Overdevest 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;2015(3):CD010036. doi: 10.1002/14651858.CD010036.pub2.
- Results publication: PubMed 29372860Schmidt 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):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.
- Results publication: PubMed 24716251Weiss 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 Quality (US); 2006 Feb-. Statistical Brief #170. Available from http://www.ncbi.nlm.nih.gov/books/NBK195245/
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Conti, Prof. principal investigator
IRCCS Istituto delle Scienze Neurologiche di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis and Degenerative Lumbar Spinal Stenosis, run by Azienda Usl di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form 12 (time frame: at baseline (day 0)). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06335511, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.