Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a simple dural patch boost recovery after spinal cord injury?

NCT ID NCT07733401

Disease control Sponsor: Xuanwu Hospital, Beijing 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This trial tests whether adding a procedure called expansile duraplasty — opening and expanding the tough membrane around the spinal cord — to standard spinal surgery can improve neurological recovery in adults with acute severe spinal cord injury. Participants are randomly assigned to receive either standard surgery alone or standard surgery plus the dural patch. The study tracks motor function, walking ability, independence, and safety over 12 months.

What this could mean

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

Active substance
expansile duraplasty (a surgical procedure that opens and expands the spinal cord covering to relieve pressure)
What this could lead to
If it works, this could point toward a better surgical approach for severe spinal cord injuries, potentially improving motor recovery and quality of life.
What could go wrong
This is a relatively small, early-stage trial, so results may not apply to all patients. The added surgery carries risks like infection or cerebrospinal fluid leak.

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 80 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

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: 1. Aged between 18 and 80 years old, with no restrictions on gender; 2. Patients diagnosed with traumatic cervical or thoracic spinal cord injury (C2-T12) via clinical evaluation including medical history collection, physical examination and auxiliary imaging tests; 3. Classified as Grade A, B or C according to the ASIA Impairment Scale (AIS) based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI); 4. Scheduled to receive surgical intervention within 72 hours after traumatic spinal cord injury; 5. Preoperative T2-weighted MRI shows no cerebrospinal fluid signal between the spinal cord and dura mater at a minimum of one vertebral segment; 6. Good general physical condition with an expected survival time of no less than 12 months; 7. Voluntarily participate in this trial, sign the written informed consent form, exhibit good compliance and cooperate with all follow-up visits; 8. Judged by attending surgeons to meet the surgical indications for posterior laminectomy and spinal internal fixation, with surgical decision-making based on surgeons' clinical experience. Exclusion Criteria: 1. Transverse spinal cord injury; 2. Gunshot or penetrating sharp spinal cord injury; 3. Pre-existing dural laceration caused by traumatic spinal cord injury; 4. Spinal cord injury without radiographic abnormality (SCIWORA, spinal injury without fracture or dislocation); 5. Acute exacerbation of pre-existing chronic spinal cord injury; 6. Traumatic spinal cord injury complicated with epidural or subdural hematoma; 7. Severe concomitant traumatic brain injury defined as a Glasgow Coma Scale (GCS) score \< 14; patients unable to follow simple verbal commands due to altered mental status; or patients with clinically significant abnormalities on cranial CT (only patients with suspected brain injury identified by investigators require cranial CT scanning); 8. Presence of underlying comorbidities that contraindicate surgery or interfere with accurate medical and neurological assessments (judged by the principal investigator).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute spinal cord injury (SCI) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

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

Acute spinal cord injury (SCI) Spinal cord injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Jiangong Hospital

    Beijing, Beijing Municipality, China

  • Beijing Shuili Hospital

    Beijing, Beijing Municipality, China

  • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

    Cangzhou, Hebei, China

  • Gaozhou Hospital of Traditional Chinese Medicine, Guangdong Province

    Maoming, Guangdong, China

  • Jinan Central Hospital, Affiliated to Shandong First Medical University

    Jinan, Shandong, China

  • Liaocheng Brain Hospital

    Liaocheng, Shandong, China

  • Shandong University Qilu Hospital (Dezhou Branch)

    Dezhou, Shandong, 253001, China

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, China

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, China

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou, Guangdong, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, China

  • Xuanwu Hospital Inner Mongolia Hospital (Chifeng City Hospital)

    Chifeng, Inner Mongolia, China

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.