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Spine graft study abandoned after only 6 patients

NCT ID NCT05614284

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to compare a man-made bone graft material called Virtuos against using the patient's own bone for lumbar spine fusion surgery in people with degenerative disc disease. The goal was to see if Virtuos could achieve similar fusion rates at 12 and 24 months. However, the trial was terminated early after enrolling only 6 participants, so no meaningful conclusions can be drawn.

What this could mean

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

Active substance
Virtuos Lyograft (bone graft substitute)
What this could lead to
If successful, this could show that Virtuos is as effective as using the patient's own bone for spinal fusion, potentially avoiding a second surgical site.
What could go wrong
The trial was terminated early with only 6 participants, so results are very limited and not reliable. It is unclear if Virtuos works as well as autograft.

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

6 people

The number who actually took part.

Started

Nov 2022

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Inclusion criteria: 1. At least 18 years of age at the time of surgery 2. Undergoing lumbar spine fusion surgery with one of the following bone grafting options: 1. Virtuos 2. Virtuos with Autograft (local bone) 3. Autograft 4. Autograft + allograft (cancellous bone chips) 3. Subject must have a documented diagnosis of DDD. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings: 1. Instability as defined by \>3mm translation or \>5 degrees angulation 2. Osteophyte formation of facet joints or vertebral endplates 3. Decreased disc height, on average by \>2mm, but dependent upon the spinal level 4. Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule 5. Herniated nucleus pulposus 6. Facet joint degeneration/changes; and/or 7. Vacuum phenomenon 4. Subject may have up to a Grade I Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena: 1. Radiculopathy 2. Sensory deficit 3. Motor weakness 4. Reflex changes 5. Subject must require lumbar posterolateral arthrodesis at 1-2 contiguous levels (L1-S1). 6. The number of levels decompressed must equal the number of levels fused. 7. Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery. 8. Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the study 9. Subject must be willing and able to sign an informed consent document. 10. Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen. Exclusion Criteria: Exclusion criteria: 1. Subject is under 18 years of age (\<18) at the time of consent 2. Subject has had prior lumbar spine fusion surgery at any level 3. Subject has greater than grade 1 spondylolisthesis of the lumbar spine 4. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted) 5. Subject is pregnant (confirmed by pregnancy test) or nursing or planning to become pregnant during the two years (24 months) following arthrodesis 6. Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection

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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.

Contacts and locations

Locations

  • Central CT Neurosurgery & Spine

    New Britain, Connecticut, 06051, United States

  • Michigan Brain and Spine

    Royal Oak, Michigan, 48073, United States

  • University of Texas South Western

    Dallas, Texas, 75390, United States

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