CompletedNot Applicable

Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study

Italy50 participantsStarted 2022-10-10

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Short Form 12

Timeframe: at baseline (day 0)

Short Form 12

Timeframe: an average of 5 days (from baseline)

Short Form 12

Timeframe: 1 months (day 30)

Short Form 12

Timeframe: 3 months (day 90)

Visual Analogue Scale

Timeframe: at baseline (day 0)

Visual Analogue Scale

Timeframe: an average of 5 days (from baseline)

Visual Analogue Scale

Timeframe: 1 months (day 30)

Visual Analogue Scale

Timeframe: 3 months (day 90)

Oswestry Disability Index

Timeframe: at baseline (day 0)

Trial details

NCT IDNCT06335511

SponsorAzienda Usl di Bologna

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-12-15

View on ClinicalTrials.gov More Lumbar Spinal Stenosis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Short Form 12

Timeframe: at baseline (day 0)

Short Form 12

Timeframe: an average of 5 days (from baseline)

Short Form 12

Timeframe: 1 months (day 30)

Short Form 12

Timeframe: 3 months (day 90)

Visual Analogue Scale

Timeframe: at baseline (day 0)

Visual Analogue Scale

Timeframe: an average of 5 days (from baseline)

Visual Analogue Scale

Timeframe: 1 months (day 30)

Visual Analogue Scale

Timeframe: 3 months (day 90)

Oswestry Disability Index

Timeframe: at baseline (day 0)