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Adult Spinal DeformityCADSNCT04194138

Complex Adult Deformity Surgery (CADS)

An observational study of Adult Spinal Deformity and Scoliosis, run by International Spine Study Group Foundation at 18 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult Spinal Deformity, Scoliosis, Kyphosis
What is being tested?
Index or spine revision surgery for complex adult spinal deformity
How many people
1,500 participants
Where
18 sitesin 2 countries
Study dates
30 Jul 2018to 31 Jul 2032
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
  • Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
  • Complex patients are defined as and meeting any one of the subsequent criteria:
  • Radiographic criteria:
  • PI-LL ≥ 25 degrees
  • TPA ≥ 30 degrees
Show all 15Show fewer
  • SVA>15cm
  • Thoracic scoliosis ≥ 70 degrees
  • Thoracolumbar/lumbar scoliosis ≥ 50 degrees
  • Global coronal malalignment >7cm
  • Procedural criteria:
  • Posterior spinal fusion > 12 levels
  • 3 column osteotomy or ACR
  • Geriatric criteria:
  • Age >65 years and minimum 7 levels of spinal instrumentation during surgery

Who cannot join

  • Age <18 years of age
  • Active spine tumor or infection
  • Deformity due to acute trauma
  • Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome)
  • Syndromic scoliosis
  • Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis)
Show all 9Show fewer
  • Prisoners
  • Women who are pregnant
  • Non English speaking patients

Trial locations and contacts

18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Christine Baldus, MS contact

618-444-4130

baldusc@wustl.edu

Ray Pinteric contact

ray.pinteric@outlook.com

18 sites in 2 countries

United States17 sites, 16 recruiting

  • John Hopkins University, Department of Orthopedic Surgery

    Baltimore, Maryland, 21224

    Ahmed Sulieman, asuliem2@jh.edu

    Khaled Kebaish, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Lorrie Sipe, 434-924-8875, lag3k@virginia.edu

    Justin Smith, MD

    Recruiting

  • Medical City Spine Hospital - Southwest Scoliosis Institute

    Dallas, Texas, 75243

    Mona Hedra, Mona.Hedra@HCAhealthcare.com

    Richard Hostin, MD

    Recruiting

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

    Denver, Colorado, 80218

    Breton Line, BS, 303-762-3472, breton.line@gmail.com

    Shay Bess, MD

    Recruiting

  • Duke University Health System

    Durham, North Carolina, 27710

    Ronald Pegues, ronald.pegues@duke.edu

    Christopher Shaffrey, MD

    Recruiting

  • University of Texas - Houston

    Houston, Texas, 77030

    Olivia Nembhard, olivia.nembhard@uth.tmc.edu

    Eric Klineberg, MD

    Recruiting

  • University of Kansas, Department of Orthopedic Surgery

    Kansas City, Kansas, 66160

    Dave Turkowitch, dturkowitch@kumc.edu

    Brandon Carlson, MD

    Recruiting

  • Shiley Center for Orthopaedic Research and Education at Scripps Clinic

    La Jolla, California, 92037

    Paulina de la Garza, 858-554-7124, delaGarza.Paulina@scrippshealth.org

    Gregory Mundis, MD

    Recruiting

  • Norton Leatherman Spine Center

    Louisville, Kentucky, 40207

    Morgan Brown, morgan.brown2@nortonhealthcare.org

    Jeff Gum, MD

    Recruiting

  • NYU, Department of Orthopedics

    New York, New York, 10016

    Connie Maglaras, constance.maglaras@nyulangone.org

    Themi Protopsaltis, MD

    Recruiting

  • Hospital for Special Surgery, Department of Orthopedic Surgery

    New York, New York, 10021

    Christopher Yoo, yooch@hss.edu

    Han Jo Kim, MD

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Erik Lewerenz, el3191@cumc.columbia.edu

    Lawrence G Lenke, MD

    Recruiting

  • Northwell Health

    New York, New York, 10075

    Jonathan Elysee, jelysee@northwell.edu

    Frank Schwab

    Recruiting

  • University Orthopedics

    Providence, Rhode Island, 02905

    Krista Szatkowski, kszatkowski@universityorthopedics.com

    Alan Daniels, MD

    Recruiting

  • University of California, Davis, Department of Orthopedic Surgery

    Sacramento, California, 05616

    Active, not recruiting

  • UCSF, Department of Neurosurgery

    San Francisco, California, 94143

    Adrian Fu, Adrian.Fu@ucsf.edu

    Christopher Ames, MD

    Recruiting

  • Spine Institute of Louisiana

    Shreveport, Louisiana, 71101

    Cody McConnell, CMcConnell@louisianaspine.org

    Pierce Nunley, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Toronto Western

    Toronto, Ontario

    Sofia Magana, Sofia.Magana@uhn.on.ca

    Stephen Lewis, MD

    Recruiting

Other trials in Canada

About this study

Official title: Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery

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.

Read the detailed description

Specific Aims:

  • 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.
  1. Complex ASD patients will be defined based upon clinical, radiographic and/or procedural criteria identified in an analysis of the existing ISSG ASD database: i. Magnitude of coronal and/or sagittal spinal deformity ≥75th percentile of patients in the ISSG database. ii. Clinical or Radiographic parameters that corresponded to patients in the ISSG database that had complications requiring revision spine surgery and/or patients that had hospital length of stay >9 days. iii. Procedures involving 3 column osteotomies and/or anterior column reconstruction (ACR) of the spine
  • Develop and validate a standardized, universal complications classification system for spine surgery
  • Evaluate perioperative blood management approaches, transfusion requirements, including variance in thresholds for blood transfusion and associated complications for adult spinal deformity surgery
  • Assess impact of opioid use and pain management on patient cost, complications and outcomes
  • Evaluate optimal opioid and analgesic usage and protocols for standard work development
  • Evaluate clinical outcomes utilizing legacy patient reported outcome measures (PROMs) including modified Oswestry Disability Index (mODI), Scoliosis Research Society Questionnaire 22r (SRS-22r), Veterans RAND-12 (VR-12), and numeric pain rating scale (NRS) and compare the results of these legacy PROMs to outcomes scores as measured by the NIH Patient Reported Outcomes Measurement Information System (PROMIS) - PROMIS Anxiety, Depression, Pain Interference, Physical Function, and Social Satisfaction. Secondary aims for PROM research for this study include
  1. Validation of the PROMIS tool for ASD
  2. Establish a core set of PROMs for best practice guidelines for ASD
  3. Evaluate patient reported outcome variance for ASD according to SRS-Schwab spine deformity type including variance in baseline PROM domains impacted and variance in improvement in PROM domains
  4. Evaluate ASD outcomes compared to population norms and investigate/develop appropriate measures of clinically significant improvement
  • Evaluate clinical outcomes stratifying by patient chronological and physiological age
  • Evaluate measures to quantify patient physiological age including patient frailty for ASD and validate a frailty measurement system for ASD
  • Evaluate the role of functional tests in patient's baseline frailty assessment including hand manometer and Edmonton Frail Scale. See appendix, pages 17 \& 18 for details.
  • Evaluate the contribution of patient frailty to patient outcomes, cost of care, disability, and complications
  • Evaluate if patient frailty is a static measure or if frailty is a dynamic measure that can be improved through "pre-habilitation" and if the according associations with reductions in frailty correlate with reductions of cost, complications, and improvement in outcomes
  • Evaluate cost variance for ASD surgery according to patient, institution, and geographical region and evaluate the cost effectiveness of surgical intervention for ASD
  • Evaluate incidence of and risk factors for mental health (MH) compromise among ASD patients and establish best practice guidelines for assessing MH for ASD patients
  • Evaluate the association of MH with surgical complications, outcomes, hospital length of stay and cost for ASD surgery
  • Evaluate the association of social health surgical complications, outcomes, hospital length of stay and cost for ASD surgery and risk factors for routine (home) discharge vs. skilled nursing facility (SNF)/rehabilitation facility
  • Broaden the evaluation of the surgically treated ASD patient to maximize evaluation of the entirety of the episode of care to include steps that can be taken prior to surgery including "prehabilitation," pain management, and MH care to improve treatment outcomes, reduce cost, reduce hospital length of stay, reduce non-routing discharge and reduce early and late complications
  • Establish a core set of standard work guidelines to clinically and radiographically evaluate and treat ASD patients and evaluate the utility of standard work to improve outcomes for ASD and formulate best practice guidelines for surgical treatment of ASD
  • Develop predictive analytic algorithms to risk stratify for best/worst outcomes, complications, sentinel events, and economic loss for ASD surgery
Being tested
Index or spine revision surgery for complex adult spinal deformity
Keywords
Scoliosis, Kyphosis, Sagittal Imbalance, Spinal deformity
Medical subject headings
Scoliosis, Kyphosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Index or spine revision surgery for complex adult spinal deformityProcedure or surgery

    Surgical interventions will be patient specified by treating surgeon.

Study groups in NCT04194138
Study groupRoleWhat they receive
OperativeA. 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
Receives: Procedure: Index or spine revision surgery for complex adult spinal deformity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scoliosis Research Society (SRS) 22r

    Scoliosis specific patient reported outcome

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  2. Oswestry Disability Index (ODI)

    Spine specific patient reported outcome

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  3. Veterans RAND 12 Item Health Survey (VR-12)

    Patient reported outcome

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  4. Radiographic Evaluation

    Cobb angles, Coronal \& Sagittal balance, spinopelvic measures

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  5. Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety

    Computer adaptive PROs

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  6. Patient-Reported Outcome Measurement Information System (PROMIS) - Depression

    Computer adaptive PRO

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  7. Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference

    Computer adaptive PRO

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  8. Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function

    Computer adaptive PRO

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  9. Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction

    Computer adaptive PRO

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  10. Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)

    Computer adaptive PRO

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  11. Visual Analog Scale - Back Pain

    Self-reported back pain on scale of 0 (No pain) to 10 (severe pain)

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  12. Visual Analog Scale - Leg Pain

    Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain)

    Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

Secondary outcomes (3)

  1. Edmonton Frail Scale

    Evaluate frailty on scale of 0 to 17 where higher scores mean more frail

    Measured: Change from Preop to 3months and 1, 2, 5 & 10 year follow-up

  2. Canadian Study of Health and Aging (CSHA)

    Frailty scale of 1 to 8; higher scores mean more frail

    Measured: Change from Preop to 3months and 1, 2, 5 & 10 year follow-up

  3. Adverse Events

    Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study

    Measured: 3 months and 1, 2, 5 & 10 year post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2019
  2. Study start30 Jul 2018
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Jul 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04194138
Sponsor's protocol ID
2123
Acronym
CADS
Status last verified
Feb 2026
First submitted
25 Nov 2019
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Boutros M, Assi A, Diebo BG, Prince G, Karam M, Daher M, Ames CP, Bess S, Daniels AH, Gupta MC, Hostin R, Kim HJ, Klineberg EO, Lenke LG, Nunley PD, Passias PG, Schwab FJ, Shaffrey CI, Smith JS, Lafage R, Lafage V; International Spine Study Group. A New Normative Zone for Acetabular Anteversion Positioning in ASD Patients. J Orthop Res. 2026 Mar;44(3):e70171. doi: 10.1002/jor.70171.

    PubMed 41761562

  • Passias PG, Tretiakov P, Onafowokan OO, Das A, Lafage R, Smith JS, Line BG, Nayak P, Diebo B, Daniels AH, Gum JL, Hamilton DK, Buell TJ, Soroceanu A, Scheer JK, Eastlack RK, Mullin JP, Schoenfeld AJ, Mundis GM, Hosogane N, Yagi M, Mummaneni PV, Chou D, Fu KM, Than KD, Anand N, Okonkwo DO, Wang MY, Klineberg E, Kebaish KM, Lewis S, Hostin R, Gupta M, Lenke L, Kim HJ, Ames CP, Shaffrey CI, Bess S, Schwab F, Lafage V, Burton D. When is staging complex adult spinal deformity advantageous? Identifying subsets of patients who benefit from staged interventions. J Neurosurg Spine. 2024 Nov 22;42(2):185-192. doi: 10.3171/2024.8.SPINE24365. Print 2025 Feb 1.

    PubMed 39576989

Questions about this trial

What is this clinical trial studying?

An observational study of Adult Spinal Deformity and Scoliosis, run by International Spine Study Group Foundation at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christine Baldus, MS (618-444-4130, baldusc@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scoliosis Research Society (SRS) 22r (time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04194138, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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