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Major spine surgery study aims to improve outcomes for 1,500 patients

NCT ID NCT04194138

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is following 1,500 adults with complex spine problems (like scoliosis or kyphosis) who are having surgery. Researchers want to learn which surgical methods work best and how to reduce complications. Participants will complete surveys about pain and quality of life, and have X-rays taken. The goal is to create guidelines that help future patients get better results.

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 1,500 people

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

Started

Jul 2018

Expected to finish

Jul 2032

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

Multi-center, prospective, non-randomized analysis of surgically treated complex adult spinal deformity (ASD) patients.

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.

Criteria: Inclusion Criteria: 1. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity 2. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot) 3. Complex patients are defined as and meeting any one of the subsequent criteria: 1. Radiographic criteria: * PI-LL ≥ 25 degrees * TPA ≥ 30 degrees * SVA\>15cm * Thoracic scoliosis ≥ 70 degrees * Thoracolumbar/lumbar scoliosis ≥ 50 degrees * Global coronal malalignment \>7cm 2. Procedural criteria: * Posterior spinal fusion \> 12 levels * 3 column osteotomy or ACR 3. Geriatric criteria: * Age \>65 years and minimum 7 levels of spinal instrumentation during surgery Exclusion Criteria: 1. Age \<18 years of age 2. Active spine tumor or infection 3. Deformity due to acute trauma 4. Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome) 5. Syndromic scoliosis 6. Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis) 7. Prisoners 8. Women who are pregnant 9. Non English speaking patients

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Conditions

The condition(s) this trial relates to.

Kyphosis scoliosis vertebral column disorder

As listed by the trial registrant

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

Adult spinal deformity Kyphosis Sagittal imbalance Scoliosis

How to take part

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

  1. The places running it

    17 sites in 2 countries. 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, 80218, United States

  • Duke University Health System

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Hospital for Special Surgery, Department of Orthopedic Surgery

    RECRUITING

    New York, New York, 10021, United States

  • John Hopkins University, Department of Orthopedic Surgery

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Medical City Spine Hospital - Southwest Scoliosis Institute

    RECRUITING

    Dallas, Texas, 75243, United States

  • NYU, Department of Orthopedics

    RECRUITING

    New York, New York, 10016, United States

  • Northwell Health

    RECRUITING

    New York, New York, 10075, United States

  • Norton Leatherman Spine Center

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Shiley Center for Orthopaedic Research and Education at Scripps Clinic

    RECRUITING

    La Jolla, California, 92037, United States

  • Spine Institute of Louisiana

    RECRUITING

    Shreveport, Louisiana, 71101, United States

  • Toronto Western

    RECRUITING

    Toronto, Ontario, Canada

  • UCSF, Department of Neurosurgery

    RECRUITING

    San Francisco, California, 94143, United States

  • University Orthopedics

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • University of California, Davis, Department of Orthopedic Surgery

    ACTIVE_NOT_RECRUITING

    Sacramento, California, 05616, United States

  • University of Kansas, Department of Orthopedic Surgery

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Texas - Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

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