Actively Recruiting

Age: 18Years +
All Genders
ID04194138

Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery

Led by International Spine Study Group Foundation · Updated on 2026-02-17

1500

Participants Needed

18

Research Sites

186 weeks

Total Duration

On this page

Sponsors

I

International Spine Study Group Foundation

Lead Sponsor

M

Medtronic

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating surgical outcomes and best practice guidelines for adults with complex spinal deformities. This study focuses on patients with adult spinal deformity (ASD), examining radiographic and clinical results, surgical and postoperative complications, risk factors for revision surgeries, and the impact of standard care processes on improving patient outcomes and reducing complications. The research aims to develop a universal system for classifying spine surgery complications and to understand factors affecting costs and mental health in ASD patients. The study involves multicenter, prospective observation of adults undergoing surgery for complex ASD, including those with congenital, degenerative, idiopathic, or iatrogenic spinal deformities. Complex cases are defined by specific radiographic measurements, extensive spinal fusion procedures, or geriatric criteria. Surgical interventions are determined by each patient's treating surgeon and may include procedures like three-column osteotomies or anterior column reconstruction. Researchers also assess blood management, opioid use, frailty, and mental health as parts of the treatment process. Participants will undergo full-body EOS radiographic assessments before surgery, with follow-up evaluations at 3 months, 1, 2, 5, and 10 years. Outcomes are measured using various tools including the Scoliosis Research Society 22r questionnaire, Oswestry Disability Index, Veterans RAND 12, and PROMIS scales for anxiety, depression, pain, physical function, and social satisfaction. The study also tracks adverse events, frailty scores, and hospital stay lengths to understand long-term clinical and social health outcomes. The study will continue monitoring participants through 2032 to gather comprehensive data on surgical effectiveness and patient well-being.

CONDITIONS

Brief Title

Complex Adult Deformity Surgery (CADS)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of adult congenital, degenerative, idiopathic, or iatrogenic spinal deformity
  • Underwent full body EOS radiographic assessment including sagittal and coronal views from skull to foot
  • Meet at least one complex patient criterion: radiographic measures (e.g., PI-LL 25 degrees, TPA 25 30 degrees, SVA >15cm, thoracic scoliosis 25 70 degrees, lumbar scoliosis 25 50 degrees, global coronal malalignment >7cm), procedural criteria (posterior spinal fusion >12 levels, 3 column osteotomy or anterior column reconstruction), or geriatric criteria (age >65 with minimum 7 levels of spinal instrumentation during surgery)
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Active spine tumor or infection
  • Spinal deformity caused by acute trauma
  • Neuromuscular conditions such as Parkinson's disease, Multiple Sclerosis, or Post-polio syndrome
  • Syndromic scoliosis
  • Inflammatory arthritis or autoimmune diseases including Rheumatoid arthritis, Lupus, or Ankylosing Spondylitis
  • Prisoners
  • Women who are pregnant
  • Non-English speaking patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay duration varies, typically over 9 days

Participants undergo complex adult spinal deformity surgery as specified by their treating surgeon, including procedures such as 3 column osteotomies and anterior column reconstruction. Surgical and immediate post-operative care are provided to manage recovery and complications.

Hospital stay with daily in-person assessments

Post-operative Follow-up

Duration - Up to 10 years following surgery

Participants attend scheduled follow-up visits to assess surgical outcomes, complications, and recovery progress. Clinical and radiographic evaluations, as well as patient-reported outcome measures, are collected over time to monitor improvement and long-term results.

Visits at 3 months, 1 year, 2 years, 5 years, and 10 years post-surgery

Trial Site Locations

Total: 18 locations

1

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

La Jolla, California, United States, 92037

Actively Recruiting

2

University of California, Davis, Department of Orthopedic Surgery

Sacramento, California, United States, 05616

Active, Not Recruiting

3

UCSF, Department of Neurosurgery

San Francisco, California, United States, 94143

Actively Recruiting

4

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

Denver, Colorado, United States, 80218

Actively Recruiting

5

University of Kansas, Department of Orthopedic Surgery

Kansas City, Kansas, United States, 66160

Actively Recruiting

6

Norton Leatherman Spine Center

Louisville, Kentucky, United States, 40207

Actively Recruiting

7

Spine Institute of Louisiana

Shreveport, Louisiana, United States, 71101

Actively Recruiting

8

John Hopkins University, Department of Orthopedic Surgery

Baltimore, Maryland, United States, 21224

Actively Recruiting

9

NYU, Department of Orthopedics

New York, New York, United States, 10016

Actively Recruiting

10

Hospital for Special Surgery, Department of Orthopedic Surgery

New York, New York, United States, 10021

Actively Recruiting

11

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

12

Northwell Health

New York, New York, United States, 10075

Actively Recruiting

13

Duke University Health System

Durham, North Carolina, United States, 27710

Actively Recruiting

14

University Orthopedics

Providence, Rhode Island, United States, 02905

Actively Recruiting

15

Medical City Spine Hospital - Southwest Scoliosis Institute

Dallas, Texas, United States, 75243

Actively Recruiting

16

University of Texas - Houston

Houston, Texas, United States, 77030

Actively Recruiting

17

University of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

18

Toronto Western

Toronto, Ontario, Canada

Actively Recruiting

Loading map...

Research Team

C

Christine Baldus, MS

R

Ray Pinteric

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

A Comparison Between Palonosetron Versus Granisetron As Post...

Postoperative Nausea and Vomiting

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

When is staging complex adult spinal deformity advantageous? Identifying subsets of patients who benefit from staged interventions.

Peter G Passias, Peter Tretiakov, Oluwatobi O Onafowokan...

https://pubmed.ncbi.nlm.nih.gov/39576989