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New study aims to improve surgery for twisted spines

NCT ID NCT04885244

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 500 adults with complex spinal deformities (like scoliosis or kyphosis) who undergo minimally invasive surgery. Researchers will measure pain, disability, and quality of life over time to find the best surgical approaches and reduce complications. The goal is to create clear guidelines for surgeons to improve patient outcomes.

What this could mean

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

Active substance
minimally invasive spine surgery
What this could lead to
If successful, this research could establish best-practice guidelines for minimally invasive surgery, leading to better outcomes and fewer complications for patients with spinal deformities.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may vary widely due to differences in surgical techniques and patient conditions.

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 500 people

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

Started

Jul 2021

Expected to finish

Dec 2034

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.

Inclusion Criteria: 1. \>18 years of age at the time of treatment 2. Diagnosis of adult congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity 3. EOS full body or standing 36" AP \& Lateral images of entire spine 4. Surgery to be schedule to take place within 6 months (otherwise PROMs/Radiographic images to be recollected) AND Either: 5. One of the following Radiographic criteria: 1. PI-LL ≥ 25 degrees 2. Thoracolumbar/lumbar scoliosis ≥ 20 degrees 3. SVA \>10cm 4. PT \> 30 OR 6. One of the Following Procedural criteria: 1. Surgery to include \> 3 levels percutaneous posterior spinal instrumentation or 3 level stand-alone interbody. (Levels = vertebra (i.e. percutaneous screws at L2, L3, L4 would be eligible for posterior instrumentation and/or L3-L4, L4-L5 would be eligible as stand-alone for interbodies) 2. Posterior UIV and LIV must be placed percutaneously 3. Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 \&/or pelvis/ilium is not) 4. Staged ≥ 3 levels fused with percutaneous pedicle screws 5. 3 column osteotomy with percutaneous fixation 6. ACR incorporating open or percutaneous fixation as long as UIV and LIV are percutaneous screws Exclusion Criteria: 1. Deformity due to acute trauma 2. Active spine tumor or infection 3. Patient is unwilling or unable to complete questionnaires 4. Women who are pregnant 5. Prisoners 6. Open Posterior spinal fusion is planned (Open Anterior, i.e. ALIF, is acceptable)

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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

    11 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

  • Barrow Neurological Institute

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Columbia University - New York-Presbyterian Och Spine Hospital

    RECRUITING

    New York, New York, 10034, United States

  • Duke University Health System

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Louisiana Spine Institute

    RECRUITING

    Shreveport, Louisiana, 71101, United States

  • Rush University, Department of Neurosurgery

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Semmes-Murphey

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Shiley Center for Orthopaedic Research and Education at Scripps Clinic

    RECRUITING

    La Jolla, California, 92037, United States

  • University of California - San Francisco Medical Center

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33125, United States

  • University of Michigan, Department of Neurosurgery

    COMPLETED

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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