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Spine surgery safety under the microscope: new study watches Real-World results

NCT ID NCT04770571

Knowledge-focused Sponsor: NuVasive 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 150 adults undergoing back-of-the-neck and upper spine surgery with metal screws and rods (posterior fixation) for injuries, tumors, or worn-out discs. Researchers track complications, X-ray results, and patient-reported pain over time. The goal is to better understand the risks and benefits of this common surgical technique.

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

May 2022

Expected to finish

Nov 2028

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

Enrolled Population The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who: * Satisfied the inclusion and exclusion criteria, * Signed the informed consent, and * Underwent the surgical procedure, as defined in this protocol. Evaluable Population The Evaluable Populations will include all subjects who: * Were included in the Enrolled Populations, * Completed the study, and * Had no major protocol deviations.

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: 1. Patients who are ≥18 years of age at the time of consent 2. Have planned craniocervical, cervical (C1 to C7), and/or upper thoracic (T1-T3) spine surgery using posterior fixation planned for treatment of any of the following conditions: 1. traumatic spinal fractures and/or traumatic dislocations 2. instability or deformity 3. failed previous fusions (e.g., pseudoarthrosis) 4. tumors involving the cervical spine 5. degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability 3. Using one of the following posterior occipito-cervico-thoracic fixation systems (NuVasive, Inc, San Diego, CA): 1. Vuepoint II OCT 2. Reline-C 4. Able to undergo surgery based on physical exam, medical history, and surgeon judgment 5. Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study Exclusion Criteria: 1. Patient is involved in active litigation relating to the spine (workers' compensation claim is allowed if it is not contested) 2. Use of bone growth stimulators postoperatively 3. Active smoking within 6 weeks of surgery 4. Patient has known sensitivity to materials implanted 5. Systemic or local infection (latent or active) or signs of local inflammation 6. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment 7. Pregnant, or plans to become pregnant 8. Patient is a prisoner 9. Patient is participating in another clinical study that would confound study data

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Conditions

The condition(s) this trial relates to.

cervical disk degenerative disorder injury intervertebral disk degenerative disorder Klippel-Feil syndrome lumbar disk degenerative disorder nervous system injury radiculopathy spinal fracture Thoracic Injuries

As listed by the trial registrant

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

Cervical disc disease Cervical fusion Cervical instabilities spine Cervical myelopathy Cervical radiculopathy Cervical spine disease Craniocervical injuries Degenerative disc disease Thoracic injury

How to take part

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

  1. The places running it

    7 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

  • Hartford Healthcare Bone & Joint Institute

    Hartford, Connecticut, 06106, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782, United States

  • NY Spine Institute

    New York, New York, 10003, United States

  • UC Irvine Medical Center

    Orange, California, 92868, United States

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15213, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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