Complex Adult Deformity Surgery (CADS)

Part of paid clinical trials in La Jolla, California.

Sponsor
International Spine Study Group Foundation
Study ID
NCT04194138
Status
Recruiting
Apply to this trial

Conditions

  • Adult Spinal Deformity
  • Kyphosis
  • Sagittal Imbalance
  • Scoliosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Index or spine revision surgery for complex adult spinal deformity — PROCEDURE
    Surgical interventions will be patient specified by treating surgeon.

Study Details

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.

Key Dates

Start date
Jul 30, 2018
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Jul 31, 2032

Study Design

Enrollment
1,500 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

Scoliosis Research Society (SRS) 22r [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Shiley Center for Orthopaedic Research and Education at Scripps ClinicLa JollaCalifornia92037
Paulina de la Garza
[email protected]
858-554-7124
Gregory Mundis, MD (PRINCIPAL_INVESTIGATOR)
Robert Eastlack, MD (SUB_INVESTIGATOR)
University of California, Davis, Department of Orthopedic SurgerySacramentoCalifornia05616-
UCSF, Department of NeurosurgerySan FranciscoCalifornia94143
Christopher Ames, MD (PRINCIPAL_INVESTIGATOR)
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical CenterDenverColorado80218
Breton Line, BS
[email protected]
303-762-3472
Shay Bess, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas, Department of Orthopedic SurgeryKansas CityKansas66160
Dave Turkowitch
[email protected]
Brandon Carlson, MD (PRINCIPAL_INVESTIGATOR)
Joshua Bunch, MD (SUB_INVESTIGATOR)
Norton Leatherman Spine CenterLouisvilleKentucky40207
Morgan Brown
[email protected]
Jeff Gum, MD (PRINCIPAL_INVESTIGATOR)
Spine Institute of LouisianaShreveportLouisiana71101
Cody McConnell
[email protected]
Pierce Nunley, MD (PRINCIPAL_INVESTIGATOR)
John Hopkins University, Department of Orthopedic SurgeryBaltimoreMaryland21224
Ahmed Sulieman
[email protected]
Khaled Kebaish, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical CenterNew YorkNew York10032
Erik Lewerenz
[email protected]
Lawrence G Lenke, MD (PRINCIPAL_INVESTIGATOR)
Hospital for Special Surgery, Department of Orthopedic SurgeryNew YorkNew York10021
Christopher Yoo
[email protected]
Han Jo Kim, MD (PRINCIPAL_INVESTIGATOR)
Northwell HealthNew YorkNew York10075
Jonathan Elysee
[email protected]
Frank Schwab (PRINCIPAL_INVESTIGATOR)
NYU, Department of OrthopedicsNew YorkNew York10016
Connie Maglaras
[email protected]
Themi Protopsaltis, MD (PRINCIPAL_INVESTIGATOR)
Duke University Health SystemDurhamNorth Carolina27710
Ronald Pegues
[email protected]
Christopher Shaffrey, MD (PRINCIPAL_INVESTIGATOR)
University OrthopedicsProvidenceRhode Island02905
Krista Szatkowski
[email protected]
Alan Daniels, MD (PRINCIPAL_INVESTIGATOR)
Medical City Spine Hospital - Southwest Scoliosis InstituteDallasTexas75243
Richard Hostin, MD (PRINCIPAL_INVESTIGATOR)
University of Texas - HoustonHoustonTexas77030
Olivia Nembhard
[email protected]
Eric Klineberg, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22908
Lorrie Sipe
[email protected]
434-924-8875
Justin Smith, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By research site
Shiley Center for Orthopaedic Research and Education at Scripps Clinic· La Jolla, CAUniversity of California, Davis, Department of Orthopedic Surgery· Sacramento, CAUCSF, Department of Neurosurgery· San Francisco, CADenver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center· Denver, COUniversity of Kansas, Department of Orthopedic Surgery· Kansas City, KSNorton Leatherman Spine Center· Louisville, KY

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