Recruiting

Observational Study

Sponsor:

International Spine Study Group Foundation

Code:

NCT04194138

Conditions

Adult Spinal Deformity

Scoliosis

Kyphosis

Sagittal Imbalance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Index or spine revision surgery for complex adult spinal deformity

Study Details

Brief summary:

Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.

Conditions

Adult Spinal Deformity

Scoliosis

Kyphosis

Sagittal Imbalance

Study ID

NCT04194138

Start date

Jul 30, 2018

Status verified date

Feb, 2026

Completion date

Jul 31, 2032

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Operative

A. Multicenter, prospective, nonrandomized analysis of operatively treated complex ASD patients meeting the following Inclusion Criteria

1. 18 years of age or greater at the time of treatment
2. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
3. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
4. Complex patients are defined as and meeting any one of the subsequent criteria:

a. Radiographic criteria: i. PI-LL ≥ 25 degrees ii. TPA ≥ 30 degrees iii. SVA>15cm iv. Thoracic scoliosis ≥ 70 degrees v. Thoracolumbar/lumbar scoliosis ≥ 50 degrees vi. Global coronal malalignment >7cm b. Procedural criteria: i. Posterior spinal fusion > 12 levels ii. 3 column osteotomy or ACR c. Geriatric criteria: i. Age >65 years and minimum 7 levels of spinal instrumentation during surgery

Interventions

Index or spine revision surgery for complex adult spinal deformity

Surgical interventions will be patient specified by treating surgeon.

Primary outcome measure

  • Scoliosis Research Society (SRS) 22r [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Oswestry Disability Index (ODI) [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Veterans RAND 12 Item Health Survey (VR-12) [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Radiographic Evaluation [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Depression [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA) [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Visual Analog Scale - Back Pain [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Visual Analog Scale - Leg Pain [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]

Central Contacts and Locations

Central contacts

Christine Baldus, MS

618-444-4130baldusc@wustl.edu

Ray Pinteric

ray.pinteric@outlook.com

Locations

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

Recruiting

La Jolla, California, United States, 92037

Contacts

Paulina de la Garza

858-554-7124delaGarza.Paulina@scrippshealth.org

Principal Investigator:

Gregory Mundis, MD

UCSF, Department of Neurosurgery

Recruiting

San Francisco, California, United States, 94143

Contacts

Adrian Fu

Adrian.Fu@ucsf.edu

Principal Investigator:

Christopher Ames, MD

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

Recruiting

Denver, Colorado, United States, 80218

Contacts

Breton Line, BS

303-762-3472breton.line@gmail.com

Principal Investigator:

Shay Bess, MD

University of Kansas, Department of Orthopedic Surgery

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Dave Turkowitch

dturkowitch@kumc.edu

Principal Investigator:

Brandon Carlson, MD

Norton Leatherman Spine Center

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Morgan Brown

morgan.brown2@nortonhealthcare.org

Principal Investigator:

Jeff Gum, MD

Spine Institute of Louisiana

Recruiting

Shreveport, Louisiana, United States, 71101

Contacts

Cody McConnell

CMcConnell@louisianaspine.org

Principal Investigator:

Pierce Nunley, MD

John Hopkins University, Department of Orthopedic Surgery

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Ahmed Sulieman

asuliem2@jh.edu

Principal Investigator:

Khaled Kebaish, MD

NYU, Department of Orthopedics

Recruiting

New York, New York, United States, 10016

Contacts

Connie Maglaras

constance.maglaras@nyulangone.org

Principal Investigator:

Themi Protopsaltis, MD

Hospital for Special Surgery, Department of Orthopedic Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Christopher Yoo

yooch@hss.edu

Principal Investigator:

Han Jo Kim, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Erik Lewerenz

el3191@cumc.columbia.edu

Principal Investigator:

Lawrence G Lenke, MD

Northwell Health

Recruiting

New York, New York, United States, 10075

Contacts

Jonathan Elysee

jelysee@northwell.edu

Principal Investigator:

Frank Schwab

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Ronald Pegues

ronald.pegues@duke.edu

Principal Investigator:

Christopher Shaffrey, MD

University Orthopedics

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Krista Szatkowski

kszatkowski@universityorthopedics.com

Principal Investigator:

Alan Daniels, MD

Medical City Spine Hospital - Southwest Scoliosis Institute

Recruiting

Dallas, Texas, United States, 75243

Contacts

Mona Hedra

Mona.Hedra@HCAhealthcare.com

Principal Investigator:

Richard Hostin, MD

University of Texas - Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Olivia Nembhard

olivia.nembhard@uth.tmc.edu

Principal Investigator:

Eric Klineberg, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Lorrie Sipe

434-924-8875lag3k@virginia.edu

Principal Investigator:

Justin Smith, MD

Toronto Western

Recruiting

Toronto, Ontario, Canada

Contacts

Sofia Magana

Sofia.Magana@uhn.on.ca

Principal Investigator:

Stephen Lewis, MD

More Information

Sponsor

International Spine Study Group Foundation

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Scoliosis
  • Kyphosis
  • Sagittal Imbalance
  • Spinal deformity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by International Spine Study Group Foundation on 2026-02-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.