Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Complex Adult Deformity Surgery (CADS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194138
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : January 29, 2020
Sponsor:
Collaborators:
Medtronic
Globus Medical Inc
SI-BONE, Inc.
Information provided by (Responsible Party):
International Spine Study Group Foundation

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.

Condition or disease Intervention/treatment
Adult Spinal Deformity Scoliosis Kyphosis Sagittal Imbalance Procedure: Index or spine revision surgery for complex adult spinal deformity

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : December 31, 2031
Estimated Study Completion Date : July 31, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort Intervention/treatment
Operative

A. Multicenter, prospective, nonrandomized analysis of operatively treated complex ASD patients B. 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
Surgical interventions will be patient specified by treating surgeon.




Primary Outcome Measures :
  1. Scoliosis Research Society (SRS) 22r [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
    Scoliosis specific patient reported outcome

  2. Oswestry Disability Index (ODI) [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
    Spine specific patient reported outcome

  3. 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

  4. Radiographic Evaluation [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
    Cobb angles, Coronal & Sagittal balance, spinopelvic measures

  5. Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
    Computer adaptive PROs

  6. Patient-Reported Outcome Measurement Information System (PROMIS) - Depression [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
    Computer adaptive PRO

  7. 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 ]
    Computer adaptive PRO

  8. 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 ]
    Computer adaptive PRO

  9. Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA) [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
    Computer adaptive PRO

  10. Visual Analog Scale - Back Pain [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
    Self-related back pain on scale of 0 (No pain) to 10 (severe pain)

  11. Visual Analog Scale - Leg Pain [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
    Self-related leg pain on scale of 0 (No pain) to 10 (severe pain)

  12. Spine radiographs [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
    Spinal measure of scoliosis, kyphosis and lordosis (degrees) in Cervical, Thoracic and Lumbar spine; pelvic parameters (pelvic incidence, tilt, slope); global alignment in coronal and sagittal plane (mm); bony fusion status.


Secondary Outcome Measures :
  1. Edmonton Frail Scale [ Time Frame: Change from Preop to 1, 2, 5 & 10 year follow-up ]
    Evaluate frailty on scale of 0 to 17 where higher scores mean more frail

  2. Canadian Study of Health and Aging (CSHA) [ Time Frame: Change from Preop to 1, 2, 5 & 10 year follow-up ]
    Frailty scale of 1 to 8; higher scores mean more frail

  3. Adverse Events [ Time Frame: 3 months and 1, 2, 5 & 10 year post treatment ]
    Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multi-center, prospective, non-randomized analysis of surgically treated complex adult spinal deformity (ASD) patients.
Criteria

Criteria:

Inclusion Criteria:

  1. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
  2. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
  3. Complex patients are defined as and meeting any one of the subsequent criteria:

    1. Radiographic criteria:

      • PI-LL ≥ 25 degrees
      • TPA ≥ 30 degrees
      • SVA>15cm
      • Thoracic scoliosis ≥ 70 degrees
      • Thoracolumbar/lumbar scoliosis ≥ 50 degrees
      • Global coronal malalignment >7cm
    2. Procedural criteria:

      • Posterior spinal fusion > 12 levels
      • 3 column osteotomy or ACR
    3. Geriatric criteria:

      • Age >65 years and minimum 7 levels of spinal instrumentation during surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194138


Contacts
Layout table for location contacts
Contact: Christine Baldus, MS 6184444130 baldusc@wustl.edu
Contact: Ray Pinteric 7209348014 Raymarla Pinteric <ray.pinteric@outlook.com>

Locations
Layout table for location information
United States, California
Shiley Center for Orthopaedic Research and Education at Scripps Clinic Not yet recruiting
La Jolla, California, United States, 92037
Contact: Tina Iannacone, MPH    858-554-7124    iannacone.tina@scrippshealth.org   
Contact: Julie McCauley, MPH       McCauley.Julie@scrippshealth.org   
Sub-Investigator: Gregory Mundis, MD         
Principal Investigator: Robert Eastlack, MD         
University of California, Davis, Department of Orthopedic Surgery Not yet recruiting
Sacramento, California, United States, 05616
Contact: Lauren Agatstein, MA    916-551-3242    lagatstein@ucdavis.edu   
Principal Investigator: Eric Kineberg, MD         
UCSF, Department of Neurosurgery Not yet recruiting
San Francisco, California, United States, 94143
Contact: Dennis Lambert       dennis.lambert@ucsf.edu   
Principal Investigator: Christopher Ames, MD         
United States, Colorado
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Breton Line, BS    303-762-3472    breton.line@healthonecares.com   
Principal Investigator: Shay Bess, MD         
United States, Kansas
University of Kansas, Department of Orthopedic Surgery Recruiting
Kansas City, Kansas, United States, 66160
Contact: Stephanie Robinson    913-588-0581    srobinson6@kumc.edu   
Principal Investigator: Douglas Burton, MD         
United States, Maryland
John Hopkins University, Department of Orthopedic Surgery Recruiting
Baltimore, Maryland, United States, 21224
Contact: Emmanuel McNeely       emcneel4@jhmi.edu   
Principal Investigator: Khaled Kebaish, MD         
United States, Missouri
Washington University, Department of Orthopedic Surgery Recruiting
Saint Louis, Missouri, United States, 63310
Contact: Brenda Sides, MS       sidesb@wustl.edu   
Sub-Investigator: Munish Gupta, MD         
Principal Investigator: Michael P Kelly, MD         
United States, New York
NYU, Department of Orthopedics Not yet recruiting
New York, New York, United States, 10016
Contact: Brooke O'Connell, MS    646-794-8643    Brooke.Oconnell@nyulangone.org   
Sub-Investigator: Themi Protopsaltis, MD         
Principal Investigator: Peter Passias, MD         
Hospital for Special Surgery, Department of Orthopedic Surgery Recruiting
New York, New York, United States, 10021
Contact: Tom Ross, RN         
Principal Investigator: Han Jo Kim, MD         
Sub-Investigator: Frank Schwab, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Meghan Cerpa, MPH    212-932-4410    mc4338@cumc.columbia.edu   
Principal Investigator: Lawrence G Lenke, MD         
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Karen Grace, RN    919-613-3801    karen.grace@duke.edu   
Principal Investigator: Christopher I Shaffrey, MD         
United States, Rhode Island
University Orthopedics Recruiting
Providence, Rhode Island, United States, 02905
Contact: Mary J Crisco, RN    401-457-2189    mjcrisco@universityorthopedics.com   
Principal Investigator: Alan Daniels, MD         
United States, Texas
Southwest Scoliosis Institute Not yet recruiting
Plano, Texas, United States, 75075
Contact: Aline Barzilla       Aline.Barzilla@HCAhealthcare.com   
Principal Investigator: Richard Hostin, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Lorrie Sipe    434-924-8875    lag3k@virginia.edu   
Principal Investigator: Justin Smith, MD         
Sponsors and Collaborators
International Spine Study Group Foundation
Medtronic
Globus Medical Inc
SI-BONE, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Shay Bess, MD Denver International Spine Center
Principal Investigator: Lawerence Lenke, MD Columbia University, Department of Orthopedic Surgery
Principal Investigator: Christopher Shaffrey, MD Duke University, Departments of Neurosurgery and Orthopaedic Surgery

Layout table for additonal information
Responsible Party: International Spine Study Group Foundation
ClinicalTrials.gov Identifier: NCT04194138    
Other Study ID Numbers: 2123
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Spine Study Group Foundation:
Scoliosis
Kyphosis
Saggittal Imbalance
Spinal deformity
Additional relevant MeSH terms:
Layout table for MeSH terms
Scoliosis
Kyphosis
Congenital Abnormalities
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases