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New bone graft could improve spinal fusion outcomes

NCT ID NCT06686017

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a special bone graft called Virtuos in people having spinal fusion surgery for degenerative disc disease. The goal is to see if it helps the bones heal together better and reduces pain and disability. About 150 adults will take part, and the study will compare their results to past patients.

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.

Participants

About 150 people

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

Started

Jun 2025

Expected to finish

Apr 2029

An estimate. End dates often move.

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.

Who is studied

The study population are patients with degenerative disc disease of the lumbar spine at one or two levels who are considered to be candidates for spinal fusion surgery by their attending physician/surgeon.

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: Subject must be 18 years of age (≥ 18 years) or older at the time of consent. * Subject must undergo lumbar interbody fusion study at 1-2 contiguous levels. * Virtuos must be the primary bone graft (≥ 50% of the total graft volume) and may be augmented with autograft or cortical or cancellous bone chips. * Subject must be willing and able to sign an informed consent document. * 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 protocol.- Exclusion Criteria: * Subject is under 18 years of age (\<18) at the time of consent. * Subject has had prior lumbar spine fusion surgery at any level. * Subject has greater than grade 1 spondylolisthesis of the lumbar spine. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted) * 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.

How to take part

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

  1. The places running it

    9 sites. 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

  • Lowcountry Orthopaedics and Sports Medicine

    North Charleston, South Carolina, 29406, United States

  • Michigan Orthopedic Surgeons

    Southfield, Michigan, 48033, United States

  • Northern Rockies Orthopaedics

    Missoula, Montana, 59804, United States

  • OrthoSC

    Myrtle Beach, South Carolina, 29579, United States

  • Pinehurst Surgical Clinic

    Pinehurst, North Carolina, 28374, United States

  • South Bend Orthopaedics

    South Bend, Indiana, 46635, United States

  • South Carolina Sports Medicine

    North Charleston, South Carolina, 29406, United States

  • Tuckahoe Orthopaedics

    Richmond, Virginia, 23226, United States

  • UT Southwestern Medical Center

    Frisco, Texas, 75033, United States

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