NCT04194138

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
76mo left

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
2 countries

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jul 2018Jul 2032

Study Start

First participant enrolled

July 30, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2032

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

10.4 years

First QC Date

November 25, 2019

Last Update Submit

February 12, 2026

Conditions

Adult Spinal DeformityScoliosisKyphosisSagittal Imbalance

Keywords

ScoliosisKyphosisSagittal ImbalanceSpinal deformity

Outcome Measures

Primary Outcomes (12)

  • Scoliosis Research Society (SRS) 22r

    Scoliosis specific patient reported outcome

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

  • Oswestry Disability Index (ODI)

    Spine specific patient reported outcome

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

  • Veterans RAND 12 Item Health Survey (VR-12)

    Patient reported outcome

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

  • Radiographic Evaluation

    Cobb angles, Coronal \& Sagittal balance, spinopelvic measures

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

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety

    Computer adaptive PROs

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

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Depression

    Computer adaptive PRO

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

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

    Computer adaptive PRO

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

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

    Computer adaptive PRO

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

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

    Computer adaptive PRO

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

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

    Computer adaptive PRO

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

  • Visual Analog Scale - Back Pain

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

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

  • Visual Analog Scale - Leg Pain

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

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

Secondary Outcomes (3)

  • Edmonton Frail Scale

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

  • Canadian Study of Health and Aging (CSHA)

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

  • Adverse Events

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

Study Arms (1)

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

Procedure: Index or spine revision surgery for complex adult spinal deformity

Interventions

Index or spine revision surgery for complex adult spinal deformityPROCEDURE

Surgical interventions will be patient specified by treating surgeon.

Operative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • SVA\>15cm
  • Thoracic scoliosis ≥ 70 degrees
  • Thoracolumbar/lumbar scoliosis ≥ 50 degrees
  • Global coronal malalignment \>7cm
  • Procedural criteria:
  • Posterior spinal fusion \> 12 levels
  • column osteotomy or ACR
  • Geriatric criteria:
  • Age \>65 years and minimum 7 levels of spinal instrumentation during surgery

You may not qualify if:

  • 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)
  • Prisoners
  • Women who are pregnant
  • Non English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

La Jolla, California, 92037, United States

RECRUITING

University of California, Davis, Department of Orthopedic Surgery

Sacramento, California, 05616, United States

ACTIVE NOT RECRUITING

UCSF, Department of Neurosurgery

San Francisco, California, 94143, United States

RECRUITING

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

Denver, Colorado, 80218, United States

RECRUITING

University of Kansas, Department of Orthopedic Surgery

Kansas City, Kansas, 66160, United States

RECRUITING

Norton Leatherman Spine Center

Louisville, Kentucky, 40207, United States

RECRUITING

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

RECRUITING

John Hopkins University, Department of Orthopedic Surgery

Baltimore, Maryland, 21224, United States

RECRUITING

NYU, Department of Orthopedics

New York, New York, 10016, United States

RECRUITING

Hospital for Special Surgery, Department of Orthopedic Surgery

New York, New York, 10021, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Northwell Health

New York, New York, 10075, United States

RECRUITING

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

University Orthopedics

Providence, Rhode Island, 02905, United States

RECRUITING

Medical City Spine Hospital - Southwest Scoliosis Institute

Dallas, Texas, 75243, United States

RECRUITING

University of Texas - Houston

Houston, Texas, 77030, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Toronto Western

Toronto, Ontario, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39576989DERIVED

MeSH Terms

Conditions

ScoliosisKyphosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Shay Bess, MD

    PRINCIPAL INVESTIGATOR

  • Lawrence Lenke, MD

    Columbia University, Department of Orthopedic Surgery

    PRINCIPAL INVESTIGATOR

  • Christopher Shaffrey, MD

    Duke University, Departments of Neurosurgery and Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Baldus, MS

CONTACT

618-444-4130baldusc@wustl.edu

Ray Pinteric

CONTACT

ray.pinteric@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 11, 2019

Study Start

July 30, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

July 31, 2032

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(17)