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New surgery could give spinal cord injury patients a better chance at recovery

NCT ID NCT07280351

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Updated 4 times

Summary

This trial tests a procedure called expansile duraplasty, where surgeons open the spinal cord's covering and sew in a patch to give the swollen cord more room. Researchers will compare recovery in 66 adults who receive this extra surgery versus those who get standard care alone. The goal is to see if the procedure leads to better movement and independence after a severe spinal cord injury.

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 the spinal cord covering and sews in a patch to create more space for swelling)
What this could lead to
If it works, this could point toward a way to improve movement and independence after a severe spinal cord injury.
What could go wrong
This is a small, early-stage trial with only 66 participants. The procedure is surgical and carries risks like infection or bleeding. It may not lead to better recovery than standard care alone.

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 66 people

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

Started

May 2026

Expected to finish

Jun 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: * In initial hospitalization for recent (less than 24 hours) acute, traumatic spinal cord injury at a participating site * Diagnosis of acute, traumatic spinal cord injury * AIS grade A - C * C3 - T10 neurological level of injury on ISNCSCI exam * Imaging showing cord compression * Surgical decompression initiated within 24 hours after injury * At sites where lumbar drain placement is standard of care: placement of lumbar drain * Able to cooperate in the completion of standardized neurological examinations Exclusion Criteria: * Injury arising from penetrating mechanism * Pregnancy * In custody * Under psychiatric hold * Presence of traumatic durotomy severe enough to preclude study treatment or procedures, in the opinion of the treating surgeon * Extensive polytrauma as determined by ISS score of \>25 * History of prior spinal cord injury * Concomitant non-traumatic spinal cord injury (e.g. infection or tumor) * Significant concomitant head injury as defined by a Glasgow Coma Scale (GCS) \<14 or a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator) * GCS Motor score \< 6 * Pre-existing neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia) * The treating surgeon deems that an anterior-only approach to decompression and/or stabilization (e.g. anterior cervical discectomy and fusion) is the best treatment plan based on the patient's injury pattern * Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator * Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study. * Thrombocytopenia, defined as less than 100,000 platelets per microliter of blood, that is not correctible by transfusion * Coagulopathy, defined as INR \> 1.4, that is not correctible by transfusion * Allergy to the study material, which may include fetal bovine tissue and collagen. * Contraindications for study treatment or procedures * Unable to give informed consent prior to their standard of care surgery

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110, United States

More trials for these conditions

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