Recruiting

Minimally Invasive Surgery

Sponsor:

International Spine Study Group Foundation

Code:

NCT04885244

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 treated with minimally invasive approach, 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

NCT04885244

Start date

Jul 28, 2021

Status verified date

Feb, 2026

Completion date

Dec 31, 2034

Anticipated

Primary completion date

Dec 31, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Operative

Multicenter, prospective, nonrandomized analysis of ASD patients w/diagnosis of congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity. Participants must be scheduled to have 3 or more levels of Percutaneous posterior spinal instrumentation or 3 level stand alone lateral surgery within next 6 months.

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 ]
  • 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 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 Role Satisfaction [ 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 ]
  • 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

6184444130baldusc@wustl.edu

Ray Pinteric

ray.pinteric@outlook.com

Locations

Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Caleb Fisher

caleb.fisher900@commonspirit.org

Principal Investigator:

Juan Uribe, MD

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

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Babak Khanderoo

babakk70@gmail.com

Principal Investigator:

Neel Anand, MD

University of California - San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Catherine Ravikumar

Catherine.Ravikumar@ucsf.edu

Principal Investigator:

Praveen Mummaneni, MD

University of Miami

Recruiting

Miami, Florida, United States, 33125

Contacts

Adriana Saravia

axf1724@med.miami.edu

Principal Investigator:

Micahael Wang, MD

Rush University, Department of Neurosurgery

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Reehan Malhance

Reehan_T_Malhance@rush.edu

Principal Investigator:

Richard Fessler, MD

Louisiana Spine Institute

Recruiting

Shreveport, Louisiana, United States, 71101

Contacts

Cody McConnell

CMcConnell@louisianaspine.org

Principal Investigator:

Pierce Nunley, MD

Columbia University - New York-Presbyterian Och Spine Hospital

Recruiting

New York, New York, United States, 10034

Contacts

Vivian Le

vl2518@cumc.columbia.edu

Principal Investigator:

Dean Chou, MD

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Ronald Pegues

ronald.pegues@duke.edu

Principal Investigator:

Khoi Than, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jan Alicandro

alicandroja@upmc.edu

Principal Investigator:

David Okonkwo, MD

Semmes-Murphey

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Sarah Lafferty

slafferty@semmes-murphey.com

Principal Investigator:

Paul Park, 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 2026-09-09. This information was provided to ClinicalTrials.gov by International Spine Study Group Foundation on 2026-02-17.