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Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery (MIS)

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ClinicalTrials.gov Identifier: NCT04885244
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : April 7, 2022
Sponsor:
Collaborator:
NuVasive
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 treated with minimally invasive approach, 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

Detailed Description:

Specific Aims:

  • Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients treated with minimally invasive approach, 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.

    a. Complex ASD patients will be defined based upon clinical, radiographic and/or procedural criteria.

  • Develop and validate a standardized, universal complications classification system for minimally invasive spine surgery
  • Evaluate perioperative blood management approaches, transfusion requirements, including variance in thresholds for blood transfusion and associated complications for minimally invasive adult spinal deformity surgery
  • Evaluate clinical outcomes utilizing legacy patient reported outcome measures (PROMs) including Scoliosis Research Society 22r (SRS 22r) modified Oswestry Disability Index (mODI), Veterans RAND-12 (VR-12), and numeric pain rating scale (NRS), and patient reported outcome measurement information system (PROMIS).
  • Evaluate clinical outcomes stratifying by patient chronological and physiological age
  • Evaluate the cost for episode of care for minimally invasive CADS surgery and cost per QALY gain compared to open surgery for CADS
  • Evaluate the contribution of patient frailty to patient outcomes, cost of care, disability, and complications
  • Evaluate incidence of and risk factors for mental health (MH) compromise among ASD patients treated with MIS techniques, and establish best practice guidelines for assessing MH
  • Evaluate the association of MH with surgical complications, outcomes, hospital length of stay and cost for MIS ASD surgery
  • Evaluate the association of social health surgical complications, outcomes, hospital length of stay and cost for MIS ASD surgery and risk factors for routine (home) discharge vs. skilled nursing facility (SNF)/rehabilitation facility
  • Broaden the evaluation of the minimally invasive 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 minimally invasive surgical treatment of ASD
  • Evaluate the use of robotic techniques in minimally invasive spine surgery for ASD, and its impact on radiographic parameters and clinical outcomes
  • Evaluate the use of expandable cages in minimally invasive spine surgery for ASD, and its impact on radiographic parameters and clinical outcomes
  • Evaluate the OR efficiency, morbidity of surgery, and cost per episode of care relating to single-position vs. multi-position CADS surgery
  • Evaluate the prevalence and incidence of sacroiliac pain before/after complex adult spinal deformity surgery.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery (MIS)
Actual Study Start Date : July 28, 2021
Estimated Primary Completion Date : December 31, 2034
Estimated Study Completion Date : December 31, 2034

Group/Cohort Intervention/treatment
Operative
Multicenter, prospective, nonrandomized analysis of ASD patients w/diagnosis of congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity. Participants must be scheduled to have 3 or more levels of Percutaneous posterior spinal instrumentation or 3 level stand alone lateral surgery within next 6 months.
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. 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 Patient reported outcome

  5. 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 Patient reported outcome

  6. 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 Patient reported outcome

  7. 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 Patient reported outcome

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

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

  10. 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

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

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


Secondary Outcome Measures :
  1. Edmonton Frail Scale [ Time Frame: Change from Preop to 3 months and 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 3 months and 1, 2, 5 & 10 year follow-up] ]
    Frailty scale of 1 to 9; higher scores mean more frail

  3. Adverse Events [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up] ]
    Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study



Information from the National Library of Medicine

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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

Inclusion Criteria:

1. >18 years of age at the time of treatment 2. Diagnosis of adult congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity 3. EOS full body or standing 36" AP & Lateral images of entire spine 4. Surgery to be schedule to take place within 6 months (otherwise PROMs/Radiographic images to be recollected) 5. Surgery to include > 3 levels percutaneous posterior spinal instrumentation or 3 level stand-alone lateral 6. And any one of the following:

a. Radiographic criteria incorporating percutaneous posterior spinal instrumentation: i. PI-LL ≥ 25 degrees ii. Thoracolumbar/lumbar scoliosis ≥ 20 degrees iii. SVA >10cm iv. PT > 30 b. Procedural criteria: i. Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 &/or pelvis/ilium is not) ii. Staged ≥ 3 levels fused with percutaneous pedicle screws iii. 3 column osteotomy with percutaneous fixation iv. ACR incorporating open or percutaneous fixation

Exclusion Criteria:

  1. Deformity due to acute trauma
  2. Active spine tumor or infection
  3. Patient is unwilling or unable to complete questionnaires
  4. Women who are pregnant
  5. Prisoners -

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): NCT04885244


Contacts
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Contact: Christine Baldus, MS 6184444130 baldusc@wustl.edu
Contact: Ray Pinteric ray.pinteric@outlook.com

Locations
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United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Luke O'Nill       luke.o'neill@commonspirit.org   
Principal Investigator: Juan Uribe, MD         
Sub-Investigator: Jay Turner, MD         
United States, California
Shiley Center for Orthopaedic Research and Education at Scripps Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Tina Iannacone, MPH    858-554-7124    iannacone.tina@scrippshealth.org   
Principal Investigator: Gregory Mundis, MD         
Sub-Investigator: Robert Eastlack, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Babak Khanderoo       babakk70@gmail.com   
Principal Investigator: Neel Anand, MD         
University of California - San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Vivian Le       vivian.le2@ucsf.edu   
Principal Investigator: Praveen Mummaneni, MD         
Sub-Investigator: Dean Chou, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33125
Contact: Esdras Lopez       exl386@med.miami.edu   
Principal Investigator: Micahael Wang, MD         
United States, Illinois
Rush University, Department of Neurosurgery Recruiting
Chicago, Illinois, United States, 60612
Contact: Ewa Gliwa       ewa_gliwa@rush.edu   
Principal Investigator: Richard Fessler, MD         
United States, Louisiana
Louisiana Spine Institute Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Brandi Casey       bcasey@louisianaspine.org   
Principal Investigator: Pierce Nunley, MD         
United States, Michigan
University of Michigan, Department of Neurosurgery Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Karen Sagher       kfrisch@med.umich.edu   
Principal Investigator: Paul Park, MD         
United States, North Carolina
Duke University Health System Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Joshua Hoover       joshua.hoover@duke.edu   
Principal Investigator: Khoi Than, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jan Alicandro       alicandroja@upmc.edu   
Principal Investigator: David Okonkwo, MD         
Sub-Investigator: Kojo Hamilton, MD         
Sponsors and Collaborators
International Spine Study Group Foundation
NuVasive
Investigators
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Principal Investigator: Praveen Mummaneni, MD University of San Francisco
Principal Investigator: Paul Park, MD University of Michigan
Principal Investigator: Gregory Mundis, MD Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA
Principal Investigator: Juan Uribe, MD Barrow Neurological Institute, Phoenix, AZ
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Responsible Party: International Spine Study Group Foundation
ClinicalTrials.gov Identifier: NCT04885244    
Other Study ID Numbers: 2138
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Sagittal Imbalance
Spinal Deformity
Additional relevant MeSH terms:
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Scoliosis
Kyphosis
Congenital Abnormalities
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases