Clinical trial NCT06335511: Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study
Official title: Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Spinal Stenosis
Degenerative Lumbar Spinal Stenosis
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2024-03-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult (\>18yrs-old) patients with symptomatic degenerative lumbar stenosis.

Brief summary: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Short Form 12
timeFrame: at baseline (day 0)
measure: Short Form 12
timeFrame: an average of 5 days (from baseline)
measure: Short Form 12
timeFrame: 1 months (day 30)
measure: Short Form 12
timeFrame: 3 months (day 90)
measure: Visual Analogue Scale
timeFrame: at baseline (day 0)
measure: Visual Analogue Scale
timeFrame: an average of 5 days (from baseline)
measure: Visual Analogue Scale
timeFrame: 1 months (day 30)
measure: Visual Analogue Scale
timeFrame: 3 months (day 90)
measure: Oswestry Disability Index
timeFrame: at baseline (day 0)
measure: Oswestry Disability Index
timeFrame: an average of 5 days (from baseline)
measure: Oswestry Disability Index
timeFrame: 1 months (day 30)
measure: Oswestry Disability Index
timeFrame: 3 months (day 90)
measure: EuroQol-5D
timeFrame: at baseline (day 0)
measure: EuroQol-5D
timeFrame: an average of 5 days (from baseline)
measure: EuroQol-5D
timeFrame: 1 months (day 30)
measure: EuroQol-5D
timeFrame: 3 months (day 90)
measure: Postural Balance
timeFrame: at baseline (day 0)
measure: Postural Balance
timeFrame: an average of 5 days (from baseline)
measure: Postural Balance
timeFrame: 1 months (day 30)
measure: Postural Balance
timeFrame: 3 months (day 90)
measure: Locomotor performance
timeFrame: at baseline (day 0)
measure: Locomotor performance
timeFrame: an average of 5 days (from baseline)
measure: Locomotor performance
timeFrame: 1 months (day 30)
measure: Locomotor performance
timeFrame: 3 months (day 90)
measure: Spinal mobility
timeFrame: at baseline (day 0)
measure: Spinal mobility
timeFrame: an average of 5 days (from baseline)
measure: Spinal mobility
timeFrame: 1 months (day 30)
measure: Spinal mobility
timeFrame: 3 months (day 90)
Secondary outcomes:
measure: Evaluation of costs
timeFrame: after 3 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzolo
city: Bologna
country: Italy
facility: IRCCS Istituto delle Scienze Neurologiche di Bologna
Study officials:
affiliation: IRCCS Istituto delle Scienze Neurologiche di Bologna
name: Alfredo Conti, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. Neurosurgery. 2017 Mar 1;80(3):355-367. doi: 10.1093/neuros/nyw091.
citation: 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.
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;2015(3):CD010036. doi: 10.1002/14651858.CD010036.pub2.
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):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.
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 Quality (US); 2006 Feb-. Statistical Brief #170. Available from http://www.ncbi.nlm.nih.gov/books/NBK195245/