Spinal stenosis surgery showdown: simpler procedure may be just as effective
NCT ID NCT07670533
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two surgical options for people who develop spinal stenosis (narrowing of the spine) above a previous fusion site. One group gets decompression alone (removing tissue pressing on nerves), while the other gets decompression plus extended fusion (adding screws and bone graft). Researchers will track pain, disability, and quality of life over two years to see which approach works better. The trial aims to enroll 192 adults who have had a prior lumbar fusion and now have symptoms like leg pain or trouble walking.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Decompression surgery alone or decompression with extended fusion (using pedicle screws and bone graft)
- What this could lead to
- If successful, this could show that a simpler surgery (decompression alone) works as well as a more complex one (with fusion) for relieving pain and disability in people with adjacent segment stenosis.
- What could go wrong
- This is a relatively small, early-stage trial (192 participants) comparing two surgical procedures, so results may not apply to all patients. Surgery carries risks like infection, nerve damage, or need for additional procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants must meet all the following criteria to be eligible for the study: 1. Clinical symptoms of spinal stenosis, defined as neurogenic claudication or radiating pain into the lower limbs with duration \>6 months 2. MRI-confirmed adjacent segment stenosis, proximal to a previously fused lumbar segment (fusion of maximum two levels between L1 and S1, any type of previous lumbar fixation procedure). 3. CT-verified solid fusion 4. Minimum time since previous fusion: one year 5. Eligible for both treatment alternatives: decompression with extended fusion and decompression alone. 6. Age between 18 and 80 years. 7. Insufficient improvement after at least 3 months of non-operative treatment. 8. Understand Norwegian language, spoken and written. Exclusion Criteria: Participants will be excluded if any of the following criteria are met: 1. Previous surgery at the actual adjacent stenotic level. 2. More than two fused lumbar levels. 3. Non-union (pseudoarthrosis) at the previously surgically fused level, radiologically verified. 4. Foraminal stenosis grade 3 at the adjacent level. 5. Spinal fracture. 6. Presence of cauda equina syndrome. 7. Complete motor deficit. 8. ASA physical status classification IV or V. 9. Alcohol or drug abuse. 10. Active cancer 11. Contradictions to MRI (e.g., Cardiac pacemaker electrodes, metal implants in the eye or brain, claustrophobia) 12. Disabling chronic neurological disease (e.g., Parkinson's disease, ALS, MS) 13. Ongoing serious psychiatric disease\& 14. Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures 15. Declining specific treatment arm 16. Are participating in another clinical trial that may interfere with this trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Innlandet Hospital Gjøvik
Gjøvik, Norway
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Oslo University Hospital HF
Oslo, Norway
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University Hospital of North Norway
Tromsø, Norway
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