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New study tracks surgery outcomes for twisted neck spines

NCT ID NCT04194996

Knowledge-focused Sponsor: International Spine Study Group Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 follows 200 adults with cervical deformity (an abnormal curve or twist in the neck spine) who are having surgery. Researchers will track pain, disability, and quality of life for up to two years after surgery. The goal is to learn which surgical methods work best and how patients recover.

What this could mean

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

Active substance
surgery
What this could lead to
If successful, this study could help doctors better understand which surgical approaches work best for cervical deformity, leading to improved outcomes for future patients.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove one surgery is better than another. Surgery itself carries risks like infection, nerve damage, or incomplete pain relief.

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 200 people

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

Started

Aug 2019

Expected to finish

Jul 2030

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.

Who is studied

Spine Surgeon Clinic

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: * ≥18 years old at time of treatment * Diagnosis of cervical deformity- must meet one or more of the following criteria: * C2-C7 sagittal kyphosis (Cobb \> 15 degrees) * T1S-CL \> 35o * Segmental cervical kyphosis \> 10 degrees between any 2 vertebra between C2-T1 or \> 15 degrees across any 3 vertebra between C2-T1 * Cervical scoliosis \> 10 degrees (Cobb angle must include end vertebra within the cervical spine) * C2-C7 SVA \> 4cm * McGregor's slope \> 20 degrees or CBVA \> 25 degrees OR * Planned Revision surgery for proximal junctional failure with an anticipated UIV in the cervical spine and an anticipated LIV in the thoracic or lumbar spine. * Plan for surgical correction of cervical deformity in the next 6 months * Willing to provide consent and complete study forms at baseline and follow-up intervals * Upright AP/Lateral entire spine (EOS or 36") * Upright AP/Lateral C spine ONLY IF C spine is not completely visible on entire spine films * Flex/Ext lateral C spine. Admin may allow exceptions w/ valid documentation. Exclusion Criteria: * Active spine tumor or infection * Deformity due to acute trauma * Unwilling to provide consent or to complete study forms * Prisoner * Pregnant or immediate plans to get pregnant

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Conditions

The condition(s) this trial relates to.

Kyphosis scoliosis

As listed by the trial registrant

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

Cervical deformity

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 and phone numbers. 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

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center

    RECRUITING

    Denver, Colorado, 80128, United States

  • Duke University Health System

    RECRUITING

    Durham, North Carolina, 27708, United States

  • Hospital for Special Surgery, Department of Orthopedic Surgery

    RECRUITING

    New York, New York, 10003, United States

  • Johns Hopkins University, Department of Neurological Surgery

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Leatherman Spine Center, Department of Orthopedic Surgery

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Medical City Spine Hospital - Southwest Scoliosis Institute

    RECRUITING

    Dallas, Texas, 75243, United States

  • New York University, Department of Orthopedic Surgery

    RECRUITING

    New York, New York, 10003, United States

  • Rush University, Department of Neurosurgery

    WITHDRAWN

    Chicago, Illinois, 60612, United States

  • Shiley Center for Orthopaedic Research and Education at Scripps Clinic

    RECRUITING

    La Jolla, California, 92037, United States

  • University of California Davis, Department of Orthopedic Surgery

    ACTIVE_NOT_RECRUITING

    Sacramento, California, 95817, United States

  • University of California-San Francisco Medical Center

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Kansas Medical Center, Department of Orthopedic Surgery

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Michigan, Department of Neurosurgery

    COMPLETED

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

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