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New Mini-Open spine surgery aims to cut recovery time for spinal stenosis patients

NCT ID NCT07279051

Symptom relief Sponsor: The First People's Hospital of Lianyungang Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a modified mini-open spine surgery (mMO-TLIF) works as well as or better than traditional open surgery for people with lumbar spinal stenosis and instability. About 224 adults aged 18 to 80 with persistent leg pain or walking problems will be randomly assigned to one of the two surgeries. Researchers will track pain, disability, blood loss, hospital stay, and complications over two years to see which approach offers better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
modified mini-open transforaminal lumbar interbody fusion (mMO-TLIF) surgery
What this could lead to
If successful, this modified surgery could offer patients with lumbar spinal stenosis a less invasive option that reduces blood loss, shortens hospital stays, and speeds up recovery while still effectively relieving pain and improving function.
What could go wrong
This is a single-center trial with 224 participants, so results may not apply to all patients. The modified surgery is still a major spine procedure with risks like infection or nerve injury, and it may not prove superior to the standard open approach.

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 224 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

May 2028

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

18 to 80 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged between 18 and 80 years. * Presence of unilateral neurogenic claudication or radicular pain in the lower limbs, with failure to respond to at least 3 months of conservative treatment. * Presence of bilateral neurogenic claudication or radicular pain in the lower limbs, but with complete resolution of neurological symptoms in at least one lower limb during recumbency and an unremarkable physical examination, alongside failure to respond to at least 3 months of conservative treatment. * Radiologically confirmed single- or two-level lumbar spinal stenosis on MRI, with evidence of instability specifically at the stenotic level(s) on standing lateral radiographs. * The mMO-TLIF or TLIF surgical procedure is performed by the same lead surgeon at each participating investigational site. * Subjects voluntarily participate and provide written informed consent. Exclusion Criteria: * Presence of bilateral radicular pain in the lower limbs that does not completely resolve at rest. * History of previous lumbar spine trauma or surgery. * Presence of spinal infection, tuberculosis, or tumor. * Contraindications to surgery, such as severe systemic medical diseases, coagulation disorders, severe active infectious diseases, or osteoporosis. * Significant intervertebral space collapse, presence of bony ankylosis, etc. * Incomplete data.

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Conditions

The condition(s) this trial relates to.

lumbar spinal stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal stenosis lumbar

How to take part

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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