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Spine surgeons test whether sparing key back tissues improves infection surgery

NCT ID NCT07817927

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers compare two back-only surgical approaches for thoracic pyogenic vertebral osteomyelitis, a bacterial infection that destroys spinal bone. One approach, PTDIF, reaches the infected area through a corridor that preserves the posterior ligamentous complex and nearby joints. The other, PLDIF, removes those structures along with a rib and part of a joint. The trial measures operative time, blood loss, pain, disability, infection markers, and complications in 89 patients.

What this could mean

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

Active substance
Posterior transforaminal debridement and interbody fusion, a spine surgery that removes infected bone and rebuilds the spine through a back-only approach
What this could lead to
If the tissue-sparing approach works as well as the standard operation, it could offer patients less blood loss, shorter surgery, and a faster recovery.
What could go wrong
This is a small trial at a single group of hospitals, so results may not apply everywhere. Both operations carry risks of infection, nerve injury, and hardware problems.

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

89 people

The number who actually took part.

Started

May 2021

Finished

Aug 2023

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 years and older

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: * Failure of conservative treatment for thoracic pyogenic vertebral osteomyelitis * Intractable back pain * Significant vertebral destruction leading to spinal instability and/or deformity * Neurological deterioration * Evident abscess formation * Diagnosis confirmed by histopathological examination, bacterial culture, and metagenomic next-generation sequencing (mNGS) Exclusion Criteria: * Patients without definitive microbiological or histopathological confirmation of PVO * Spinal tuberculosis (excluded via T-SPOT.TB assay and other diagnostic workup)

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Changde First People's Hospital

    Changde, Hunan, 410008, China

  • Changsha Central Hospital

    Changsha, Hunan, 410008, China

  • Xiangya Boai Rehabilitation Hospital

    Changsha, Hunan, 410008, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008, China