NCT06335511

Brief Summary

Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

February 11, 2026

Status Verified

July 1, 2025

Enrollment Period

2.2 years

First QC Date

March 13, 2024

Last Update Submit

February 9, 2026

Conditions

Lumbar Spinal StenosisDegenerative Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (28)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • Spinal mobility

    Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).

    at baseline (day 0)

  • 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)

  • Spinal mobility

    Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).

    1 months (day 30)

  • 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 Outcomes (1)

  • Evaluation of costs

    after 3 years

Study Arms (2)

Decompression

microsurgical decompression (MiD)

Procedure: microsurgical decompression

Fusion

decompression and instrumented fusion (MiD + F)

Procedure: decompression and instrumented fusion

Interventions

microsurgical decompressionPROCEDURE

decompression of neurological structures

Also known as: decompression
Decompression
decompression and instrumented fusionPROCEDURE

decompression of neurological structures and spine stabilization

Also known as: stabilization
Fusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult (\>18yrs-old) patients with symptomatic degenerative lumbar stenosis.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS Istituto Ortopedico Rizzolo

Bologna, Bologna, 40136, Italy

Location

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Bologna, 40139, Italy

Location

Related Publications (6)

  • 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.

    PMID: 26824399RESULT

  • 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. Neurosurgery. 2017 Mar 1;80(3):355-367. doi: 10.1093/neuros/nyw091.

    PMID: 28362963RESULT

  • 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 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.

    PMID: 27074067RESULT

  • 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;2015(3):CD010036. doi: 10.1002/14651858.CD010036.pub2.

    PMID: 25760812RESULT

  • 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):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.

    PMID: 29372860RESULT

  • 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 Quality (US); 2006 Feb-. Statistical Brief #170. Available from http://www.ncbi.nlm.nih.gov/books/NBK195245/

    PMID: 24716251RESULT

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Decompression

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPressureMechanical PhenomenaPhysical Phenomena

Study Officials

  • Alfredo Conti, Prof.

    IRCCS Istituto delle Scienze Neurologiche di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 28, 2024

Study Start

October 10, 2022

Primary Completion

December 15, 2024

Study Completion

February 28, 2025

Last Updated

February 11, 2026

Record last verified: 2025-07

Locations

IT(2)