Spine surgery showdown: which Tiny-Incision procedure wins for seniors?
NCT ID NCT07482826
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of keyhole spine surgery for middle-aged and older adults with lumbar spinal stenosis, a condition that causes leg pain and trouble walking. One surgery just removes the tissue pressing on nerves, while the other also fuses the bones together. The goal is to see which approach provides better pain relief and recovery with fewer risks.
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
-
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
-
About 176 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Apr 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2029
An estimate. End dates often move.
- Lead sponsor
-
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
-
50 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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: 1. Aged between 50 and 75 years, regardless of gender. 2. A definitive diagnosis of lumbar spinal stenosis, presenting with typical clinical symptoms (e.g., lower extremity radiating pain, neurogenic claudication) and signs, confirmed by imaging (MRI or CT). 3. The lesion involves only a single spinal segment (L2-S1). 4. Failed to respond to at least three months of systematic conservative treatment, with a significant impact on quality of life, and the patient has a clear willingness to undergo surgery. 5. (Clinical equipoise) After evaluation by at least two senior spine surgeons, both agree that the patient's condition meets the surgical indications for both full-endoscopic decompression and endoscopic lumbar interbody fusion. 6. The patient fully understands the randomized nature of this study (including random assignment and the relinquishment of choice by both the physician and the patient) and voluntarily signs the Informed Consent Form. Exclusion Criteria: 1. Clear indications for fusion: Degenerative spondylolisthesis greater than Meyerding Grade I, presence of lumbar spondylolysis, or evidence of definite lumbar instability on flexion-extension radiographs (e.g., segmental translation \> 3 mm or angular change \> 10°). 2. Clear indications for decompression alone: Stenosis caused solely by soft disc herniation, without concomitant bony spinal canal or lateral recess stenosis. 3. Spinal stenosis due to non-degenerative causes: Presence of spinal stenosis caused by fracture, spinal tumor, active infection, or inflammatory disease (e.g., ankylosing spondylitis, rheumatoid arthritis). 4. Severe spinal structural abnormalities: Presence of severe spinal deformity (e.g., degenerative scoliosis with a Cobb angle \> 20°). 5. History of relevant prior surgery: Previous lumbar surgery at the same or an adjacent segment. 6. Systemic diseases precluding tolerance to surgery: Presence of severe dysfunction of major organs (e.g., heart, lung, liver, kidney) or an American Society of Anesthesiologists (ASA) classification \> III, indicating an inability to tolerate anesthesia or surgery upon evaluation. 7. Comorbidities that may confound outcome assessment: Presence of other conditions that could cause lower extremity claudication or dysfunction, such as severe hip or knee osteoarthritis (including a history of total hip or knee arthroplasty), peripheral vascular claudication, or polyneuropathy. Presence of other neurological or muscular system disorders that could seriously affect treatment evaluation (e.g., Parkinson's disease, amyotrophic lateral sclerosis). 8. Participation in other studies: Currently participating in other clinical trials that could potentially influence the results of this study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Spinal stenosis lumbar are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A conversation before spine surgery could change how patients recover
- Virtual reality could rewire the mind for better spine surgery recovery
- Spinal disc protein may signal Wear-and-Tear severity
- Can a growth factor from donor bone improve spinal fusion?
- Can one injection beat back pain? a trial aims to find out
- Spinal implant aims to stabilize the back and ease pain