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 range

18 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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)

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 range

18 Years

Sex

ALL

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)